University of Wisconsin–Madison
Clinical Research Carbone Center

Clinical Research Program

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

The Department of Surgery Clinical Research Program is 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.

  • 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 Research

Cardiothoracic Surgery

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Principal Investigator(s): Takushi Kohmoto, MD, PhD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02362646

MOMENTUM 3: Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE-Clinical Study Protocol
Principal Investigator(s): Takushi Kohmoto, MD, PhD
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): Takushi Kohmoto, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT02892955

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Principal Investigator(s): Nilto DeOliveira, MD
Status: 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: 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: 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

STRATA2014: An open-label, controlled, randomized, multicenter, dose-escalation study evaluating the safety, tolerability and efficacy of single or multiple applications of StrataGraft skin tissue as an alternative to autografting full-thickness complex skin defects
Principal Investigator(s): Angela Gibson, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT03005054

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

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: Recruiting
ClinicalTrials.gov: NCT03005106

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

Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Principal Investigator(s): David M Melnick, MD, MPH
Status: Active, not recruiting
ClinicalTrials.gov: NCT02414841

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

Preoperative tamsulosin for the prevention of postoperative urinary retention: a randomized, double-blind, placebo-controlled trial
Principal Investigator(s): Evie Carchman, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT02486653

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot (TSOS 6)
Principal Investigator(s): Amy Liepert, MD
Status: Recruiting
ClinicalTrials.gov: NCT02335125

A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in Treated Patients
Principal Investigator(s): Heather Neuman, MD
Status: Recruiting
ClinicalTrials.gov: NCT02910557


Otolaryngology–Head & Neck Surgery

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: Recruiting
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: Recruiting

The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures during High Resolution Pharyngeal Manometry
Principal Investigator(s): Jodi Hernandez, CCC-SLP
Status: Active, not recruiting
ClinicalTrials.gov: NCT03349112

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: Active, not recruiting

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

Correlations between laryngeal and pharyngeal function in older adults
Principal Investigator(s): Molly Knigge, CCC-SLP
Status: Recruiting

Effects of Cervical Bracing on Elderly Patients with Dysphagia
Principal Investigator(s): Jodi Hernandez, CCC-SLP
Status: Active, not recruiting
ClinicalTrials:gov: NCT03349125


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


Plastic Surgery

Finger Replantation ANd amputation-CHallenges in assessing Impairment, Satisfaction and Effectiveness (FRANCHISE) Study
Principal Investigator(s): Brett Michelotti, MD
Status: Active, Not 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

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

A randomized, open label, multicenter study of a belatacept-based early glucocorticoid withdrawal regimen with alemtuzumab or rabbit antithymocyte globulin induction compared to a tacrolimus-based early glucocorticoid withdrawal regimen with rabbit antithymocyte globulin induction in renal transplantation. [T-cell co-stimulatory blocker] (BEST)
Principal Investigator(s): Dixon Kaufman, MD, PhD
ClinicalTrials.gov: NCT01729494

Immunosuppression with Antithymocyte Globulin, Rituximab, Tacrolimus, Mycophenolate Mofetil and Sirolimus, Followed by Immunosuppression Withdrawal in Living-donor Renal Transplant Recipients (Immune Tolerance Network-ITN039ST- RESTARRT)
Principal Investigator(s): Dixon Kaufman, MD, PhD
ClinicalTrials.gov: NCT01318915

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

A Phase Ib, Single and Multiple-dose, Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Obinutuzumab in Adults with End Stage Renal; Disease and Hypersensitization Awaiting Renal Transplantation (THEORY)
Principal Investigator(s): Robert Redfield, MD
ClinicalTrials.gov: NCT02586051

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


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

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

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

Zenith® p-Branch® Pivotal Study
Principal Investigator(s): Girma Tefera, MD
Status: Recruiting
ClinicalTrials.gov: NCT02396199

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

Roadster 2: REGISTRY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (ROADSTER 2) 
Principal Investigator(s): Paul DiMusto, MD
Status: Recruiting
ClinicalTrials.gov: NCT02536378

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

GORE® Carotid Stent Clinical Study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy: The Gore Scaffold Clinical Study
Principal Investigator(s): Girma Tefera, MD
Status: Active, not recruiting
ClinicalTrials.gov: NCT01901874

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

Relay-Pro-A: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms (TAAs) and Penetrating Atherosclerotic Ulcers (PAUs)
Principal Investigator(s): Dai Yamanouchi, MD, PhD
Status: Recruiting
ClinicalTrials.gov: NCT02818972

Contact Us


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


Otolaryngology Trials
doll@surgery.wisc.edu
(608) 262-5213


Transplantation Trials
schneide@surgery.wisc.edu
(608) 263-7064