Research Innovation & Invention Impactful Research DEI, Collaborative, & Basic & Translation Research Research by Condition Clinical Trials Seed Grants Resources Clinical Trials UC Irvine Department of Surgery Home About Campus & Community Resources Surgery: Research > Clinical Trials Investigator-Initiated Clinical Trials Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery (PROJECT-BARI) NCT05975580 PI: Kishore Gadde, MD This study assesses if the use of phentermine or topiramate (or a combination) helps reverse weight regain in patients who have undergone bariatric surgery. LEARN MORE Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections NCT06002607 PI: Areg Grigorian, MD Researchers are investigating how a 48-hour course of antibiotics compares to a seven-day course for the treatment of necrotizing soft tissue infections, in terms of safety, hospital length of stay and in-hospital complications, including unplanned return to the operating room, ventilator days and antibiotic-associated complications. Serum precalcitonin levels are also being assessed to identify a percentage decrease that suggests resolution of infection. LEARN MORE Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures: A Randomized Controlled Trial NCT05321121 PI: Jeffry Nahmias, MD Investigators are evaluating the off-label use of a dexmedetomidine infusion for analgesia in patients with multiple rib fractures to determine if it will decrease patient pain and opioid use. LEARN MORE Empiric Calcium in Massive Transfusion NCT05953376 PI: Jeffry Nahmias, MD Hypocalcemia, known to occur with transfusion and in patients with hemorrhagic shock, may be associated with increased mortality. Trauma patients who require massive transfusion within six hours of their arrival will be assigned to either early empiric intravenous calcium administration or calcium supplementation based on blood levels. Investigators will compare transfusion requirements, vasopressor use and mortality in the two groups. LEARN MORE Study of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis (STOPGAP) NCT04762953 PI: Maheswari Senthil, MD Patients with histologically proved primary gastric or gastroesophageal junction adenocarcinoma with positive peritoneal cytology, positive peritoneal lavage and/or peritoneal carcinomatosis will receive sequential systemic and intraperitoneal chemotherapy to assess the safety and efficacy of this regimen. LEARN MORE Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis NCT05844865 PI: Maheswari Senthil, MD Patients with a gastrointestinal primary tumor with or without peritoneal carcinomatosis will provide biospecimen collections (blood, ascites/peritoneal wash fluid and/or tumor samples) during planned standard of care surgeries to establish and evaluate the angioarchitecture of peritoneal lesions through optical coherence tomography angiography. LEARN MORE Sponsored Multicenter Clinical Trials Department of Surgery faculty participate in various sponsored multicenter clinical trials and serve as the site principal investigator of these clinical trials: Joseph Carmichael, MD, “A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection” Anthony Chau, MD, “CCR-23-02: DEFIANCE RCT of ClotTriever System vs. Anticoagulation in Deep Vein Thrombosis” and “CCR-23-24: EndurAnt Stent Graft system vs ExcluDer endoprothesis: A global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)” Samuel Chen, MD, “CCR-23-85: A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular lesions located in the infrapoplitEal Arteries beLow the knee (DEEPER REVEAL)” Theresa Chin, MD, “CCR-20-131: A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL System Combined with Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction” Oliver Eng, MD, “Alliance A022101/NRG-GI009: A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients with Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur Trial)” Roy Fujitani, MD: “A Phase 3 Study to Compare the Efficacy and Safety of Humacyte Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End-Stage Renal Disease” “A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma” David Imagawa, MD, PhD: “An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects with Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma” “A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma, Including FGFR2 Translocations Who Failed Previous Therapy” “UCI 18-10: PACER (Pancreatic AdenoCarcinoma with Electron intraoperative Radiation Therapy): A Phase II Study of Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients with Pancreatic Cancer with Vascular Involvement” “UCI-19-106: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)” “Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma” Victor Joe, MD, “Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries” Zeljka Jutric, MD, “Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial” Nii-Kabu Kabutey, MD: “Randomized, Multicenter, Controlled Trial to Compare Best Endovascular Versus Best Surgical Therapy in Patients with Critical Limb Ischemia” “A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers” “A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta” “CCR-20-159: Evaluation of a Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications” “Anchor Aneurysm Treatment Using the Aptus Heli-FX EndoAnchor System Global Registry” Hari Keshava, MD, “UCI 21-221: Development of Personalized Immunotherapies for Esophageal Cancer” Steven Mills, MD, “CCR-22-34: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection (PROFILE)” Jeffry Nahmias, MD, “CCR-21-123: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra / Beriplex]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleed” Robert Redfield, MD: “CCR-23-65: A Dose Escalation and Proof-of-Concept Study of Regn5459 or Regn5458 (BCMA_CD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen” “CCR-23-66: A Noninterventional Extension Study for Patients Treated in Study R5459-rt-1944 With Regn5459 or Regn5458 (Bcma_Cd3 Bispecific Antibodies) Who Receive a Kidney Transplant” “CCR-23-79: BESTOW: A Phase 2, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation” Sebastian Schubl, MD, “CCR-22-35: Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair with RibFix Advantage” Skandan Shanmugan, MD, “CCR-23-04: SPOTLITE: ProSPective ObservaTionaL Study on the Clinical Outcomes of Surgical InTErventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)” Matthew Whealon, MD, “Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) with Laparoscopic Assistance for Rectal Cancer” Maki Yamamoto, MD, “UCI-21-106: A Phase 2 Open-label, Dose-Finding Study to Determine the Optimal Dose for Lymph Node Visualization Using ASP5354 in Participants with Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy”