Clinical trials: Anastomosis
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
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
Familial Adenomatous Polyposis Coli, FAP
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA
This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance…
- Trial name
- NCT00510692
- Testing
- Eicosapentanoic Acid (EPA), Endoscopy, Biopsies taken
- Where
- United Kingdom
- Volunteers
- 58 people
- Sponsor
- S.L.A. Pharma AG
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
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
Gastrointestinal Disease, Colorectal Disease
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
- Trial name
- Tiger (NCT00888849)
- Testing
- Advant 55 Linear Cutter/Stapler, Suturing
- Where
- 3 sites in India
- Volunteers
- 280 people
- Sponsor
- Ethicon Endo-Surgery
Gastric Ulcer (GU), Duodenal Ulcer (DU)
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old…
- Conditions
- Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU), Non-erosive Reflux Esophagitis Disease (NERD)
- Trial name
- NCT02153398
- Testing
- D961H sachet 10 mg, D961H capsule 10mg, D961H capsule 20 mg
- Where
- 15 sites in Japan
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Gastric Outlet Obstruction
Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction…
- Trial name
- MAD (NCT00487552)
- Testing
- Cook Magnetic Anastomosis Device (MAD) with Stent
- Where
- 4 sites in Belgium, Italy and 1 more
- Volunteers
- 18 people
- Sponsor
- Cook Group Incorporated
Vascular Anastomosis Surgery
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03103282
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 65 people
- Sponsor
- 3-D Matrix Europe SAS
Gastrointestinal Diseases
The EVICEL® Gastrointestinal Study
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
- Trial name
- NCT01589822
- Testing
- EVICEL Fibrin Sealant
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 214 people
- Sponsor
- Ethicon, Inc.
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
Rectal Cancer, Rectosigmoid Cancer
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using…
- Trial name
- PILLAR III (NCT02205307)
- Testing
- PINPOINT, SPY Elite
- Where
- 24 sites in United States
- Volunteers
- 347 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
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
Colorectal Cancer
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
- Trial name
- NCT00559013
- Testing
- Staple line reinforcement
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Baxter Healthcare Corporation
Obesity
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost.
- Trial name
- NCT00394212
- Testing
- Transoral Suturing
- Where
- 10 sites in United States
- Volunteers
- 77 people
- Sponsor
- C. R. Bard
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
Refractory Anastomotic Esophageal Strictures
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture
The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures
- Trial name
- E7025 (NCT01699542)
- Testing
- WallFlex Esophageal RX Fully Covered Stent, Esophageal Bougie Dilator Per Investigator preference
- Where
- 4 sites in Brazil, Netherlands and 1 more
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
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
Left-sided Colon Resection
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
- Trial name
- EPMCS-CA (NCT03326895)
- Testing
- Left-sided colon resection
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 168 people
- Sponsor
- Ethicon Endo-Surgery