Clinical trials: Ileostomy
Subjects With an Ileostomy
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
- Trial name
- NCT01800890
- Testing
- Coloplast A, Coloplast B, Coloplast C
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of a New Supporting Ostomy Product
The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their…
- Trial name
- NCT04374890
- Testing
- CP308
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Coloplast A/S
Obesity, Type 2 Diabetes Mellitus (T2DM)
Magnetic Duodeno-Ileal Chile Study
The objective of the MagDI Chile Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side…
- Trial name
- NCT06613724
- Testing
- Magnet System, DI Biofragmentable
- Where
- Chile
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Ileostomy - Stoma, Colostomy - Stoma
A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or…
- Trial name
- TIES IV (NCT07413822)
- Testing
- TIES® Transcutaneous Implant Evacuation System
- Volunteers
- 10 people
- Sponsor
- Asian Institute of Gastroenterology, India
Ileostomy - Stoma
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.
- Trial name
- NCT03953170
- Testing
- Teduglutide
- Where
- United States
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Colostomy Stoma, Ileostomy - Stoma
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test…
- Trial name
- OUTFLOW (NCT06394115)
- Testing
- Ostomy pouch
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- ConvaTec Inc.
Ileostomy; Complications
A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the…
- Trial name
- NCT05985499
- Testing
- Suturing of ileostomy using "Dumpling suture method", Suturing of ileostomy using Traditional suture method
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Rectal Cancer, Total Mesorectal Excision
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).
- Conditions
- Rectal Cancer, Total Mesorectal Excision, Ileostomy - Stoma, Ileostomy; Complications
- Trial name
- TIMES (NCT05284864)
- Testing
- Stoma closure
- Where
- 9 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Hospital Universitario La Fe
Rectal Cancer
Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer.
- Trial name
- NCT02665026
- Testing
- stoma closure at different times
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Huashan Hospital
Ileostomy, Rectal Neoplasms
Diverting Loop Ileostomy: With or Without Rod
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a…
- Trial name
- ROLLI (NCT00959738)
- Testing
- Diverting loop ileostomy with rod, diverting loop ileostomy without rod
- Where
- Switzerland
- Volunteers
- 121 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Bowel Obstruction, Bowel Ischemia
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of…
- Conditions
- Bowel Obstruction, Bowel Ischemia, Diverticulitis, Abnormality of the Gastrointestinal Tract
- Trial name
- NCT04709445
- Testing
- ICG-NIRF Imaging plus ingress and egress analysis
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Ileostomy - Stoma
Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being…
- Trial name
- ILEO (NCT03941522)
- Testing
- Early discharge from hospital
- Where
- 2 sites in Canada
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
- Trial name
- NCT03462563
- Testing
- INTERCEED™
- Where
- 12 sites in China
- Volunteers
- 175 people
- Sponsor
- Ethicon, Inc.
Ileostomy - Stoma
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output.
- Trial name
- NCT06897163
- Testing
- Specialized Absorbent Intestinal Tampon
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Ampa Medical
Stoma Ileostomy
Evaluation of the Peel Force of New Adhesives From the Skin
This study investigates the impact and adhesion of new adhesives to the skin.
- Trial name
- NCT03200444
- Testing
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Short Bowel Syndrome
Osmolality of Oral Supplements and Ileostomy Output
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight…
- Conditions
- Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion, Nutritional Deficiency
- Trial name
- NCT03348709
- Testing
- Isoosmolar, Hyperosmolar
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- University of Aarhus
Ileostomy - Stoma, Rectal Neoplasms
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection.
- Trial name
- NCT06344923
- Testing
- Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing, Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Hospital of Shandong University
Healthy Volunteers With Ileostomy
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy
- Trial name
- NCT02473640
- Testing
- SYN-004, Esomeprazole, Ceftriaxone
- Where
- 2 sites in Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Type 2 Diabetes, Obesity
MagDI Diversion Feasibility Study
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side…
- Trial name
- NCT05692518
- Testing
- MAGNET System, DI Bio-fragmentable
- Where
- Georgia
- Volunteers
- 15 people
- Sponsor
- GT Metabolic Solutions, Inc.