Active Clinical Trials

Cardiothoracic Surgery

The portable Organ Care System (OCS) Heart for Resuscitation. Preservation and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Principal Investigator(s): Jason Smith, MD
IRB# 2021-0011
Status: Recruiting
Clinical Trials.gov: NCT04615182

PLOTS Registry: Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
Principal Investigator(s): Malcolm M. DeCamp, MD, FACS
IRB# 2019-1518
Status: Active, not recruiting
ClinicalTrials.gov: NCT 04066699

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Principal Investigator(s): Satoru Osaki, MD, PhD
IRB# 2016-1183
Status: Active, not recruiting
ClinicalTrials.gov: NCT02675244

(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
IRB# 2019-0934
Status: Active, not recruiting
Clinical Trials.gov: NCT03831048

(PACES CTSN) Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG
Principal Investigator(s): Satoru Osaki, MD
IRB# 2020-1422
Status: Recruiting
ClinicalTrials.gov: NCT04045665

General Surgery

ICG Burn: Novel application of indocyanine green as a biomarker to identify tissue necrosis in burn patients.
Principal Investigator(s): Angela Gibson, MD, PhD
IRB# 2019-1274
Status: Recruiting

ABRUPT: The Acute Burn ResUscitation Multicenter Prospective Trial
Principal Investigator(s): Angela Gibson, MD, PhD
IRB# 2017-0761
Status: Active, not 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): Amber L. Shada, MD, FACS
IRB# 2018-0734
Status: Not recruiting
ClinicalTrials.gov: NCT03495154

STRATACAT: A multicenter, open-label, study of StrataGraft^® skin tissue in Adult subjects with deep partial thickness burns
PI: Angela Gibson, MD, PhD
IRB# 2020-0035
Status: Recruiting
ClinicalTrials.gov: NCT04123548

Intraoperative use of the OTIS™ (Optical Tissue Imaging System) in Surgically Excised Lumpectomy Breast Tissue (Pre-RCT)
Principal Investigator(s): Lee Wilke, MD
Status: Active, not recruiting

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

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

Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Principal Investigator(s): Daniel E. Abbott, MD, FACS
IRB# 2020-0487
Status: Recruiting
Clinicaltrials.gov:NCT04239573

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

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

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

Behavioral Basis of the Perception of Emotion Expression in Clinical Populations with Facial Paralysis
Principal Investigator(s): Scott Chaiet, MD, MBA
IRB# 2015-0366
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
IRB# 2019-0406
Status: Active, not recruiting
Clinical Trials,gov: NCT04148872

Pediatric Surgery

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Principal Investigator(s): Adam S. Brinkman, MD, FACS, FAAP
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): Charles M. Leys, MD, FACS
IRB# 2019-1423
Status: Recruiting
Clinicaltrials.gov:NCT03615495

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

Migraine/MRI – Changes in neuroimaging and neurocognition in chronic migraine patients following extracranial nerve decompression.
Principal Investigator(s): Ahmed M. Afifi, MD
Status: Recruiting

Abdominoplasty – Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty.
Principal Investigator(s): Venkat K. Rao, MD, MBA
IRB# 2019-1570
Status: Not yet recruiting

Breast Reconstruction Database – Breast Reconstruction Database Repository.
Principal Investigator(s): Ahmed M. Afifi, MD
Status: Recruiting

Nutrition in Breast Reconstruction – Evaluating the Use of Enhanced Recovery Properative Immuonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction.
Principal Investigator(s): Katherine M. Gast, MD, MS
Status: Recruiting

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

Transplantation

Use of dd-cfDNA in Multi-Organ Transplant Rejection Detection (MOTR)
Principal Investigator(s): Jon Odorico, MD
IRB# 2021-0279
Status: Recruiting

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
IRB# 2018-0821
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): Anthony M. D’Alessandro, MD
IRB# 2017-1325
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): Arang Djamali, MD, MS
IRB# 2017-1385
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
IRB# 2017-5062
Status: Recruiting
ClinicalTrials.gov: NCTNCT03363945

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
IRB# 2016-5048
Status: Active, not recruiting
ClinicalTrials.gov: NCT02775162

Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy For Deceased Donor Kidney Transplant Recipients (CTOT-19)
Principal Investigator(s): David Foley, MD
IRB# 2016-1208
Status: Active, not recruiting
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
IRB# 2018-0660
Status: Recruiting
ClinicalTrials.gov: NCT03292445

Non Invasive Blood Test to Diagnose Acute Rejection After Pancreas and Kidney Transplantation. Pancreas and Renal Rejection Diagnosis Using Circulation Donor-Derived Cell-free DNA in Peripheral Blood (PANCDx).
Principal Investiagor(s): Jon Odorico, MD
IRB# 2020-0195
Status: Recruiting
ClinicalTrials.gov: NCT04166149

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): Jon Odorico, MD
IRB# 2016-5004
Status: Active, not recruiting
ClinicalTrials.gov: NCT02644941

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
IRB# 2014-1341
Status: Active, Recruiting
ClinicalTrials.gov: NCT02060630

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)
Principal Investigator(s): Jon S. Matsumura, MD
IRB# 2016-1406
Status: Active, not recruiting
ClinicalTrials.gov: NCT02089217

Carotid Revascularization and Medical Management for Asymptomatic Carotid Senosis – Hemodynamics (CREST-H)
Principal Investigator(s): Jon S. Matsumura, MD
IRB# 2018-0026
Status: Active, not recruiting
ClinicalTrials.gov: NCT03121209

Global Registry for Endovascular Aortic Treatment Outcomes Evaluation (GREAT)
Principal Investigator(s): John R Hoch, MD
IRB# 2013-5023
Status: Active, not recruiting
ClinicalTrials.gov: NCT01658787

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
IRB# 2012-5017
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
IRB# 2016-5084
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): Kyla M. Bennett, MD, FACS
IRB# 2016-5056
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
IRB# 2014-5016
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): Paul D. DiMusto, MD
IRB# 2015-5090
Status: Recruiting
ClinicalTrials.gov: NCT02489539

Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (AAA 17-01)
Principal Investigator(s): Dai Yamanouchi, MD, PhD
IRB# 2020-0997
Status: Recruiting
ClinicalTrials.gov: NCT03728985

Clinical Trials Research Program

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Surgery Trials
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