Clinical trials: Low Anterior Resection
Low Anterior Resection Syndrome
Randomized Clinical Trial on Transanal Irrigation
Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care. The secondary objective is to investigate quality of life and different benefits and aspects of treatment…
- Trial name
- NCT04586634
- Testing
- Peristeen cone catheter
- Where
- Denmark
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
Gastroenterology, LARS - Low Anterior Resection Syndrome
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment…
- Conditions
- Gastroenterology, LARS - Low Anterior Resection Syndrome, Rectal Cancer
- Trial name
- MINIGO (NCT06923150)
- Where
- 9 sites in France
- Volunteers
- 78 people
- Sponsor
- Qufora A/S
Rectal Cancer
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
A preliminary Study in Subjects Undergoing Low Anterior Resection
- Trial name
- NCT01790230
- Testing
- LifeSeal™ Kit
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- LifeBond Ltd.
Thoracic, Colorectal Disorders
Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy…
- Trial name
- ISI-I3DM-01 (NCT06434727)
- Testing
- observational study
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Intuitive Surgical
Colorectal Cancer
Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
The purpose of this study is: Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
- Trial name
- NCT01056796
- Testing
- CAR™ 27
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Niti Medical Technologies Ltd.
Rectal Cancer, Colon Cancer
Perfusion Assessment in Laparoscopic Left Anterior Resection
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic…
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp
- Trial name
- PILLAR II (NCT01560377)
- Testing
- PINPOINT Endoscopic Fluorescence Imaging System
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Anastomotic Leakage
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an…
- Trial name
- NCT02881359
- Testing
- LifeSeal® Kit
- Where
- 8 sites in Belgium, Netherlands
- Volunteers
- 200 people
- Sponsor
- LifeBond Ltd.
Rectal Cancer, Anastomotic Leak
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
- Trial name
- NCT02907385
- Testing
- LifeSeal™ Kit
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 736 people
- Sponsor
- LifeBond Ltd.
Colorectal Cancer
Radial Reload Laparoscopic LAR Case Series
To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.
- Trial name
- NCT01706822
- Testing
- Covidien Radial Reload Stapler with Tri-Staple Technology
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medtronic - MITG
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
Rectal Cancer
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)
This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer.
- Trial name
- NCT04359498
- Where
- 8 sites in United States, Canada
- Volunteers
- 372 people
- Sponsor
- Safeheal
Colorectal Anastomosis, Left-sided Colon Resection
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in…
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication
- Trial name
- SECURE (NCT07351071)
- Testing
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Where
- 10 sites in United States
- Volunteers
- 137 people
- Sponsor
- Medtronic - MITG
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
Low Anterior Resection, Proctosigmoid Resection
Radial Reload Open LAR Case Series
The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.
- Conditions
- Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
- Trial name
- NCT01717014
- Testing
- Covidien Radial Reload Stapler with Tri-Staple Technology
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Medtronic - MITG
LARS - Low Anterior Resection Syndrome
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
- Trial name
- NCT05527301
- Testing
- Lactobacillus Fermentum
- Volunteers
- 67 people
- Sponsor
- HEM Pharma Inc.