Clinical trials: Stoma
Colostomy Stoma
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.
- Trial name
- NCT02544061
- Testing
- NM-IL-12
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neumedicines Inc.
Incisional Hernia
PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
Rationale: Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a parastomal herniation is high, with a reported incidence of 4-48%.
- Trial name
- PROMISS (NCT03750942)
- Testing
- Adhesix® monofilament polypropylene mesh (Bard Davol)
- Where
- Netherlands
- Volunteers
- 130 people
- Sponsor
- Maastricht University Medical Center
Laryngeal Cancer, Laryngectomy
SpeakFree Heat and Moisture Exchanger (HME)
The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME).
- Trial name
- SPEAKFREE (NCT05349487)
- Testing
- SpeakFree HME Hands Free Valve, Digital Occlusion, Digital Depression HME
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Miami
Rectal Cancer Surgery
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current…
- Trial name
- NCT07429110
- Testing
- ColoSeal ICD System, Protective Diverting Ostomy
- Where
- 9 sites in United States, New Zealand
- Volunteers
- 250 people
- Sponsor
- Averto Medical, Inc.
Ileostomy - Stoma, Colostomy
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
- Trial name
- NCT02517541
- Testing
- SenSura Mio Convex Soft
- Where
- 9 sites in United States, Netherlands and 2 more
- Volunteers
- 74 people
- Sponsor
- Coloplast A/S
Morbid Obesity
Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
Executive Summary Aims and Hypotheses of the Study: The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in…
- Trial name
- NCT01025076
- Testing
- StomaphyX
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- University of Alberta
Stoma Site Incisional Hernia
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH).
- Trial name
- NCT05627284
- Testing
- Stoma reversal with bio-mesh placement
- Where
- China
- Volunteers
- 58 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Colon Cancer, Rectal Cancer
Stoma Closure and Reinforcement Trial
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of…
- Conditions
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- Trial name
- SCAR (NCT03750461)
- Testing
- Mesh Implantation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Ulcerative Colitis, Ileal Pouch
MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process…
- Conditions
- Ulcerative Colitis, Ileal Pouch, Anastomotic Leak
- Trial name
- NCT04719169
- Testing
- Dynamic MRI enema, Fluoroscopic enema
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- London North West Healthcare NHS Trust
Diverticular Disease of Colon, Colostomy Complication
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
Brief Summary This multicenter study compares the effectiveness of primary anastomosis with diverting loop ileostomy to Hartmann's procedure for managing perforated sigmoid diverticulitis in stable patients.
- Conditions
- Diverticular Disease of Colon, Colostomy Complication, Colostomy - Stoma
- Trial name
- ARES (NCT06794905)
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
Stoma Site Leakage
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Trial name
- NCT04544566
- Testing
- Test product A, Test product B, Comparator
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Wearing a New Adhesive
The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.
- Trial name
- NCT03200431
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Coloplast A/S
Peritonitis Caused by Perforated Left-sided Colon Diverticulitis
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to…
- Trial name
- NCT01239927
- Testing
- Primary sigmoid resection with end colostomy (Hartmann), Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Ente Ospedaliero Ospedali Galliera
Enterocolitis, Necrotizing, Atresia; Bowel
Timing of Stoma Closure in Neonates
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel.
- Conditions
- Enterocolitis, Necrotizing, Atresia; Bowel, Gastroschisis, Meconium Ileus
- Trial name
- ToSCiN (NCT04713579)
- Testing
- No intervention - observational study
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- Manchester University NHS Foundation Trust
Colorectal Cancer, Stoma - Ileostomy
SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year.
- Trial name
- SAFE-3CV (NCT07116668)
- Testing
- Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
- Where
- 18 sites in United States, Belgium and 2 more
- Volunteers
- 108 people
- Sponsor
- SafeHeal Inc