N/A N=25 Investigation of a Supporting Ostomy Product Intended for Leakage Detection
Stoma Ileostomy
Primary: System Performance Accuracy of Pictures — 122; 126; 24; 45 Pictures
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=122 Performance Study of Newly Developed Ostomy Products
Stoma Colostomy
Primary: Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full…
N/A N=112 Stoma Closure and Reinforcement Trial
Colon Cancer · Rectal Cancer · Ileostomy - Stoma
Primary: Number of Participants With Wound Occurrences — 0 Participants
N/A N=37 Investigation of the Performance of Ostomy Base Plate
Ileostomy - Stoma
Primary: Leakage Under the Base Plate — 8.2; 5.5; 8.0 units on a scale
N/A N=100 Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation
Stoma Ileostomy · Stoma Colostomy
Primary: Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks — 1.57; 0.93 Number of leakages per two weeks…
N/A N=22 The Influence of Baseplate Adhesive on the Degree of Leakage
Colostomy Stoma · Ileostomy Stoma
Primary: Degree of Leakage — 3.6; 2.4; 5.5; 4.8 units on a scale
Phase 3 N=54 Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Colostomy
Primary: Leakage (Percent of All Base Plates With Leakage) — 27; 30 Percent of Base plates
N/A N=20 A Clinical Investigation of New Ostomy Appliances
Leakage
Primary: Leakage Under the Base Plate Using a 24-point Scale — 4.5; 3.3; 4.4 units on a scale
N/A N=22 Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
Ileostomy - Stoma
Primary: Degree of Leakage — 4; 4.6; 2.6 units on a scale
N/A N=144 Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
Ileostomy - Stoma · Colostomy Stoma
Primary: Emotional Impact Score (Scale From 0-100) — 73.4; 62.0 score on a scale — p=<0.001
N/A N=7 Fluorescent Evaluation of Colorectal Anastamoses
Rectal Neoplasms · Colon Neoplasms · Diverticulitis
Primary: Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One…
Phase 4 N=27 A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Urostomy
Primary: Preference of Sensura vs Moderma — 45; 43 percentage of prefering the product
N/A N=25 An Investigation of Ostomy Devices
Ileostomy
Primary: Degree of Leakage — 4.2; 4.3; 4.4; 4.3 units on a scale
N/A N=47 Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Surgical Stomas
Primary: Leakage Through Coupling Registered at Each Bag Change (Yes/no) — 0.151; 0.237 Proportion of bag changes/participant — p=0.164
N/A N=23 Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Ileostomy - Stoma · Colostomy Stoma
Primary: Trans Epidermal Water Loss — 39.0; 35.9 g/m^2/h
N/A N=50 LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa
Abdominal Site · Colostomy Site
Primary: Skin Irritation as Measured by Draize Score for Erythema and Edema — 0.86; 0.03; 0; 0.38 score on a scale — p=<0.0001
Phase 3 N=168 Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Pancreatic Fistula
Primary: Number of Patients With Pancreatic Fistula — 9; 8 participants
N/A N=170 The Advocate Study
Ostomy
Primary: Stoma Related Cost of Care — 223.73; 260.19 USD
N/A N=28 A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
Ileostomy - Stoma
Primary: Degree of Leakage — 6.4; 3.4; 7.0; 7.0 units on a scale
Phase 4 N=120 Parastomal Reinforcement With Strattice
Parastomal Hernia
Primary: Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. — 6; 7 participants
N/A N=11 The Cascade Feasibility Pilot (Ileostomy)
Ileostomy; Complications · Ileostomy - Stoma
Primary: Attrition Rate — 2 Participants
N/A N=38 Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Colorectal Cancer
Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
N/A N=17 Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Dermatologic Complications
Primary: Skin Barrier Peel Force — 150; 215 grams
N/A N=38 A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
Ileostomy - Stoma
Primary: Trans Epidermal Water Loss — 19.6; 20.7; 24.1 g/m^2/h
N/A N=31 Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Ileostomy - Stoma
Primary: Leakage (Percentage of All Baseplates With Leakage) — 34; 35 percentage baseplates with leakage
N/A N=10 Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)
Transfemoral Amputation
Primary: Bacterial Community Types as Determined by Percentage RNA Sequence Reads — 3.4; 4.6; 4.7; 8.7 Percentage RNA sequence reads — p=<0.05
N/A N=702 Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Colorectal Surgery
Primary: Surgical Site Infection (SSI) Rate — 16; 14; 6; 1 Participants
N/A N=355 Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Morbid Obesity
Primary: Number of Participants With Postoperative Gastrointestinal Hemorrhage — 13; 39 participants
N/A N=12 A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Stoma Site Leakage
Primary: Mean Adherent Area Measured by Photo of Used Tape — 46.54; 51.61; 52.94 Cm2
N/A N=40 Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device
Polyp of Colon · Fistula
Primary: Time to Closure — 23.3; 18.4 minutes