Clinical Research Carbone Center

Clinical Research Program

Our Clinical Research Program provides faculty and staff with comprehensive support to conduct clinical research studies at the University of Wisconsin.

We are committed to conducting the highest quality clinical research and offering innovative new therapies to our patients, aiming to improve short and long-term patient outcomes. The dedicated clinical research staff has extensive experience in all areas of pharmaceutical and device research including Phase 1 through Phase 4 drug development, compassionate use protocols, investigator held IND studies, bioequivalence and pharmacokinetic studies, and IDE device studies.

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Our Services

The Surgery Clinical Research Program is designed to handle multiple clinical trials simultaneously, to meet and exceed enrollment goals and to facilitate rapid budget and contract turn around to promote timely study initiation.

  • Coordinate all aspects of clinical research studies including multi-center trials and investigator-initiated research
  • Provide administrative, regulatory, and operational support to investigators to promote rapid study initiation and implementation
  • Support outcomes and disease management research
  • Implement translational research projects
  • Coordinate Phase I/II drug/biologic development trials
  • Assist faculty with identifying clinical research opportunities within area of expertise
  • Coordinate the Department of Surgery’s clinical research efforts with research sponsors, University of Wisconsin Hospital and Clinics, American Family Children’s Hospital, Meriter Hospital, VA Medical Center, and collaborators in other UW departments and academic centers
  • Provide biostatistics support for clinical research for safety (DSMB) and endpoint analysis
Regulatory Support
  • Assist with all types of IRB submissions
  • Prompt and complete submissions to local and central IRBs
  • Maintain all sponsor and FDA regulatory documentation
  • Assist with preparation of FDA IND submissions
  • Monitor and Improve clinical research compliance
Administrative Support
  • Assist Department of Surgery faculty with designing clinical research protocols for investigator-initiated studies
  • Provide investigator training and educational opportunities
  • Protocol feasibility evaluation
  • Clinical trial budget development and negotiation
  • Identify new clinical trial opportunities
  • Financial oversight of clinical research accounts and activities
Study Coordination

The program is staffed by highly trained, competent, and experienced clinical research coordinators

  • Provide inpatient and outpatient coordination of all phases of clinical trials
  • Recruitment of eligible subjects
  • Comprehensive subject follow up
  • Timely data entry and query resolution
  • PK/PD sampling capabilities
  • Bio-sample collection, processing, storage, and shipping

Clinical Research Facilities

  • Office and lab space in Wisconsin Institutes for Medical Research (WIMR) and Clinical Science Center (CSC) which are connected to University of Wisconsin Hospital and Clinics (UWHC), American Family Children’s Hospital (AFCH), UW Health at the American Center (TAC) and the VA Medical Center (VAMC)
  • Pharmaceutical Research Center for drug storage, dispensation, and maintenance
  • Lab space includes:
    • refrigerated centrifuge
    • microcentrifuge
    • sterile hood
    • dry ice
    • -80 and -20 degree freezers
  • Ample locked storage space for study files
  • Conference rooms with wireless internet access for monitoring visits
  • On-site phlebotomy and clinical lab services

Active Clinical Trials

Cardiothoracic Surgery

MOMENTUM 3: Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE-Clinical Study Protocol
Principal Investigator(s): Amy Fiedler, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02224755

MOMENTUM 3 CAP Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol
Principal Investigator(s): Amy Fiedler, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02892955

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Principal Investigator(s): Nilto DeOliveira, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02675244

A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury induced by Cardiopulmonary Bypass in Pediatric Subjects Undergoing Surgery for Congenital Heart Defects (Protocol CIT-003-01)
Principal Investigator(s): Petros Anagnostopoulos, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02891837

Bloodbased biomarkers for minimal residual disease monitoring in patients undergoing surgical resection for the treatment of lung cancer
Principal Investigator(s): James Maloney, MD
Status: Recruiting

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Principal Investigator(s): Satoru Osaki, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT03510897

(OCS Heart U.S DCD Heart Trial) Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death
Principal Investigator(s): Jason Smith, MD
Status: Not yet recruiting
Clinical Trials.gov: NCT03831048

(PACES CTSN) Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG
Principal Investigator(s): Satoru Osaki, MD
Status: Not yet recruiting


General Surgery

ABRUPT: The Acute Burn ResUscitation Multicenter Prospective Trial
Principal Investigator(s): Angela Gibson, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT03144427

A Multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair
Principal Investigator(s): Jacob Greenberg, MD, EdM
Status: Recruiting
ClinicalTrials.gov: NCT03495154

STRATA2016: Open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue as an alternative to autografts in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns and that contain intact dermal elements
Principal Investigator(s): Angela Gibson, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT03005106

STRATACAT: A multicenter, open-label, study of StrataGraft® skin tissue in Adult subjects with deep partial thickness burns
PI: Angela Gibson, MD, PhD
Status: Not yet recruiting

A Prospective, Multi-Center Study of Phasix ST Mesh for Laparoscopic Ventral or Incisional Hernia Repair
Principal Investigator(s): Jacob A. Greenberg, MD, EdM
Status: Active, not recruiting
ClinicalTrials.gov: NCT02712398

A Prospective, Multi-Center Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Principal Investigator(s): Jacob A. Greenberg, MD, EdM
Status: Active, not recruiting
ClinicalTrials.gov: NCT01961687

Intraoperative use of the OTIS™  (Optical Tissue Imaging System) in Surgically Excised Lumpectomy Breast Tissue (Pre-RCT) 
Principal Investigator(s): Lee Wilke, MD
Status: Recruiting

MSLT-II: A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection Versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients With Molecular or Histopathological Evidence of Metastases in the Sentinel Node
Principal Investigator(s): Heather B Neuman, MD, MS, FACS
Status: Active, not recruiting
ClinicalTrials.gov: NCT00297895

A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
Principal Investigator(s): Lee Wilke, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT00881361

Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Principal Investigator(s): Rebecca S Sippel, MD
Status: Recruiting
ClinicalTrials.gov: NCT02138214

PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Natural History Registry for Patients With Chronic Hypoparathyroidism
Principal Investigator(s): Rebecca S Sippel, MD
Status: Recruiting
ClinicalTrials.gov: NCT01922440

A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Principal Investigator(s): Sharon Weber, MD
Status: Recruiting
ClinicalTrials.gov: NCT03269994


Otolaryngology–Head & Neck Surgery

PRO-ACTIVE: Comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer
Principal Investigator(s): Timothy M. McCulloch, MD
Status: Recruiting
ClinicalTrials.gov: NCT03455608

Effects of Vocal Exercise following Botox Injection on Voice Handicap and Communicative Participation for Adductor Spasmodic Dysphonia
Principal Investigator(s): Brienne Ruel, CCC-SLP
Status: Completed Recruitment
ClinicalTrials.gov: NCT03349086

Prevalence of Penetration and Aspiration during Flexible Endoscopic Evaluation of Swallowing in Healthy Adults
Principal Investigator(s): Carol Tolejano, CCC-SLP
Status: Active, not recruiting

Voice-related Outcomes in response to Intensive versus Traditional Therapy Programs
Principal Investigator(s): Emerald Doll, CCC-SLP
Status: Recruiting
ClinicalTrials.gov: NCT03129880

Factors Affecting Adherence to Postprocedure Voice Rest
Principal Investigator(s): Susan Thibeault, PhD, CCC-SLP
Status: Recruiting

Swab sampling vs. mucosal biopsy for characterization of the human laryngeal microbiome
Principal Investigator(s): Susan Thibeault, PhD, CCC-SLP
Status: Recruiting

Comparing Quality of Life and Perceptual Speech Ratings in Children with Cleft Palate
Principal Investigator(s): Susan Thibeault, PhD, CCC-SLP
Status: Completed Recruitment

Yale Swallow Protocol in recently extubated patients
Principal Investigator(s): Stevie Marvin, CCC-SLP
Status: Recruiting
ClinicalTrials.gov: NCT03352908

Treatment and patient-reported treatment outcomes in children and adolescents with paradoxical vocal fold motion (PVFM)
Principal Investigator(s): Bryn Olson-Greb, CCC-SLP
Status: Recruiting

Behavioral Bases of the Perception of Emotion Expression in Clinical Populations with Facial Paralysis
Principal Investigator(s): Scott Chaiet, MD, MBA
Status: Not yet recruiting

Self-Reported Gender-Voice Incongruence and Voice-Health Information Seeking Behaviors in Transgender and Non-Gender-Conforming Individuals
Principal Investigator (s): Susan Thibeault, PhD, CCC-SLP
Status: Active, not recruiting

SLP Practice Patterns: Vocal Health Care for Individuals with Traumatic Brain Injury (TBI)
Principal Investigator(s): Susan Thibeault, PhD, CCC-SLP
Status: Active, not recruiting

Mixed Methods Investigation of Chronic Facial Paralysis in Individuals with Synkinesis: Study of Outcomes Before and After Treatment
Principal Investigator(s): Scott Chaiet, MD, MBA
Status: Active, Recruiting
Clinical Trials,gov: NCT04148872


Pediatric Surgery

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Principal Investigator(s): Peter F Nichol, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT01990040

SHP633-303: A retrospective and prospective, open label, long-term safety and efficacy study of teduglutide in pediatric patients with short bowel syndrome who completed TED-C13-003
Principal Investigator(s): Peter F Nichol, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02949362

SHP633-304-A prospective, open label, long-term safety and efficacy study of teduglutide in pediatric patients with short bowel syndrome who participated in TED-C14-006
Principal Investigator(s): Peter F Nichol, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02954458

Flourish™ Pediatric Esophageal Atresia Device
Principal Investigator(s): Jonathon Kohler, MD
Status: Not yet recruiting


Plastic Surgery

Enhanced Recovery Strategies in Elective Breast Surgery
Principal Investigator(s): Venkat Rao, MD, MBA
Status: Recruiting

Composite Tissue Allotransplantation (CTA) Repository (UW)
Principal Investigator(s): Michael Bentz, MD
Status: Not yet recruiting

Composite Tissue Allotransplantation (CTA) Repository (VA)
Principal Investigator(s): Samuel Poore, MD
Status: Not yet recruiting


Transplantation

Conversion from Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of functional, safety and quality of life outcomes (CIRTEN SPK)
Principal Investigator(s): Jon Odorico, MD
Status: Recruiting
ClinicalTrials.gov: NCT03769298

A Phase I/II, Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Human Recombinant C1 Inhibitor (RUCONEST®) as a therapeutic strategy to reduce the incidence of Delayed Graft Function in recipients of kidneys from Donation after Cardio-circulatory Death (Ruconest DCD)
Principal Investigator(s): Luis Fernandez, MD
Status: Recruiting
ClinicalTrials.gov: NCT03791476

CAMPath and BELimumab for the Induction of Donor Specific Humoral Transplant Tolerance in Sensitized Kidney Transplant Recipients To Improve Long-Term Allograft Survival (CAMPBEL)
Principal Investigator(s): Robert Redfield, MD
Status: Recruiting
ClinicalTrials.gov: NCT03591380

A Phase 3 Prospective, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants [MERCURY]
PrincipaI Investigator(s):  Dixon Kaufman, MD, PhD
ClinicalTrials.gov: NCTNCT03363945

Maternal Microchimerism and Neonatal Tolerance
Principal Investigator(s): William Burlingham, PhD

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant (ReGIFT)
Principal Investigator(s): David Foley, MD
ClinicalTrials.gov: NCT02610296

A Comparison of the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of a PTFE Graft in Subjects undergoing Hemodialysis (HUMANITY)
Principal Investigator(s): Robert Redfield, MD
ClinicalTrials.gov: NCT02644941

A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation (ORGANOX)
Principal Investigator(s): Anthony D’Alessandro, MD
ClinicalTrials.gov: NCT02775162

Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation (ASTOUND)
Principal Investigator(s): Dixon Kaufman, MD, PhD
ClinicalTrials.gov: NCT02723591

Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy For Deceased Donor Kidney Transplant Recipients (CTOT-19)
Principal Investigator(s): David Foley, MD
ClinicalTrials.gov: NCT02495077

Influence of Microbial Communities on Transplant Immunology (The Microbiome and Transplant)
Principal Investigator(s): Josh Mezrich, MD

(Stanford Tolerance) Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in Living Donor Kidney Transplantation
Principal Investigator(s): Dixon Kaufman, MD
Status: Not yet recruiting


Vascular Surgery

Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) 
Principal Investigator(s): John R Hoch, MD
Status: Recruiting
ClinicalTrials.gov: NCT02060630

The Impact of Diabetes on Revascularization in BEST-CLI (TIDE)
Principal Investigator (s): John R Hoch, MD
Status: Recruiting
ClinicalTrials.gov: NCT03085524

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)
Principal Investigator(s): Girma Tefera, MD
Status: Recruiting
ClinicalTrials.gov: NCT02089217

Carotid Revascularization and Medical Management for Asymptomatic Carotid Senosis – Hemodynamics (CREST-H)
Principal Investigator(s): Girma Tefera, MD
Status: Recruiting
ClinicalTrials.gov: NCT03121209

Global Registry for Endovascular Aortic Treatment Outcomes Evaluation (GREAT)
Principal Investigator(s): John R Hoch, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT01658787

Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated AAA Endovascular Graft Post-Approval Study
Principal Investigator(s): Girma Tefera, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT01990950

A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)
Principal Investigator(s): Dai Yamanouchi, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT01664078

Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
Principal Investigator(s): Dai Yamanouchi, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02407457

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Pathologies of the Aortic Arch and Descending Thoracic Aorta (SSB 11-02) 
Principal Investigator(s): Charles W. Acher, MD
Status: Recruiting
ClinicalTrials.gov: NCT02777528

Evaluation of the GORE ® EXCLUDER ® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms (CIAA) and Aorto-iliac Aneurysms
Principal Investigator(s): Charles W. Acher, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT01883999

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms (AAA 13-03)
Principal Investigator(s): Charles W. Acher, MD
Status: Recruiting
ClinicalTrials.gov: NCT02489539

 

Clinical Research Staff

Lauren Addison

Financial Specialist Advanced

sheehan@surgery.wisc.edu

(608) 263-7385

Thomas Boland

Clinical Research Coordinator

bolandt@surgery.wisc.edu

(608) 263-9459

Elizabeth Costa

Clinical Research Coordinator, CCRC

costa@surgery.wisc.edu

(608) 262-9799

Derek Gonzalez

Clinical Research Coordinator

gonzalez@surgery.wisc.edu

(608) 265-6648

Kaelin Grant

Research Program Manager, CCRC

grantk@surgery.wisc.edu

(608) 262-1551

Bridget Johnson

Clinical Program Coordinator - Vascular

johnsonbri@surgery.wisc.edu

(608) 263-1400

Adam Krajewski

Regulatory Manager

krajewski@surgery.wisc.edu

(608) 265-6460

Lekha Nelavelli

Clinical Research Coordinator

nelavelli@surgery.wisc.edu

(608) 262-9383

David Platt

Clinical Research Coordinator

platt@surgery.wisc.edu

(608)263-2565

Daniel Vang

Clinical Research Coordinator

vangd@surgery.wisc.edu

(608) 262-0299

Katalin Vinkler

Regulatory Specialist

vinkler@surgery.wisc.edu

(608) 265-1257

Contact Us


Surgery Trials
clinicalresearch@surgery.wisc.edu
(608) 262-0540


Otolaryngology Trials
lynchm@surgery.wisc.edu
(608) 263-4864