Clinical trials: Surgical Anastomosis
Gastric Cancer
Perianastomotic Drain After Gastrectomy (DRAG)
Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total…
- Trial name
- DRAG (NCT04288661)
- Testing
- No drain placement
- Where
- Greece
- Volunteers
- 60 people
- Sponsor
- THEODOROU DIMITRIOS
Medium and Lower Rectal Cancer
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Hypothesis: In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65.
- Trial name
- CASCADOR (NCT01876901)
- Testing
- 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA), Colo-anal anastomosis (CAA)
- Where
- 9 sites in France
- Volunteers
- 124 people
- Sponsor
- Institut Bergonié
Coronary Artery Bypass Surgery
Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia
In spite improvements in methods of myocardial protection, peri-operative myocardial damage is still the commonest cause of early morbidity and mortality after technically successful CABG Surgery.
- Trial name
- MACBC (NCT02303704)
- Testing
- multiport antegrade cardioplegia, Aortic root antegrade cardioplegia
- Volunteers
- 448 people
- Sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
Colorectal Anastomosis
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods to be used for educational…
- Trial name
- NCT00713661
- Testing
- TachoSil®
- Where
- 3 sites in Germany, Netherlands and 1 more
- Volunteers
- 25 people
- Sponsor
- Nycomed
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Colorectal Cancer, Rectal Cancer
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- SAFE-2 (NCT05010850)
- Testing
- Colovac, Stoma Creation
- Where
- 16 sites in United States, Belgium and 1 more
- Volunteers
- 18 people
- Sponsor
- SafeHeal Inc
Heart Defects, Congenital
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries.
- Trial name
- XEL-CR-06 (NCT02377700)
- Testing
- Xeltis Vascular Patch, Model COR-VP-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Prostate Cancer
Global Performance Evaluation of the AMS CONTINUUM™ Device
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2.
- Trial name
- NCT01083199
- Testing
- CONTINUUM™
- Where
- 2 sites in Greece, Spain
- Volunteers
- 10 people
- Sponsor
- American Medical Systems
Colorectal Surgery
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
- Trial name
- COMPRES (NCT01091155)
- Testing
- ColonRing (Colorectal anastomosis)
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 288 people
- Sponsor
- novoGI
Ileus, Post-Operative Adhesions
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel…
- Trial name
- PROFILE (NCT02836470)
- Testing
- LB1148
- Where
- 28 sites in United States
- Volunteers
- 112 people
- Sponsor
- Palisade Bio
Ulcerative Colitis, Pouchitis
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more…
- Trial name
- NCT06316999
- Testing
- Intestinal Ultrasound
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
Cardiac Transplant, Patent Ductus Arterious
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis…
- Conditions
- Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
- Trial name
- NCT00480740
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Children's National Research Institute
Gastrointestinal Neoplasm
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear…
- Trial name
- NCT05320029
- Testing
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler, ECHELON Flex Powered Articulating Endoscopic Linear Cutters
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Fengh Medical Co., Ltd.
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Esophageal Cancer
Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine…
- Trial name
- NCT02609425
- Testing
- Stratafix PGA Suture
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Anastomosis
Comparison Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy
The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after laparoscopic right hemicolectomy compared with that of side-to-side anastomosis.
- Trial name
- NCT02897531
- Testing
- ES anastomosis, SS anastomosis
- Where
- 2 sites in South Korea
- Volunteers
- 130 people
- Sponsor
- Seoul National University Hospital
Colorectal Cancer
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
- Trial name
- NCT06540807
- Testing
- Colovac Colorectal Anastomosis Protection Device, Stoma creation
- Where
- Uzbekistan
- Volunteers
- 24 people
- Sponsor
- SafeHeal Inc