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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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
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=127 Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Stoma Ileostomy
Primary: Degree of Leakage — 5.1; 5.8 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=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=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=52 Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Ileostomy · Colostomy
Primary: Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". — 56.9; 10.6; 29.4; 27.7 percentage of subjects answering
N/A N=11 The Cascade Feasibility Pilot (Ileostomy)
Ileostomy; Complications · Ileostomy - Stoma
Primary: Attrition Rate — 2 Participants
N/A N=55 Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
Ileostomy · Colostomy
Primary: Fit to Body — 93; 88; 57 percentage of good or very good
N/A N=18 Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Ileostomy - Stoma
Primary: Degree of Leakage — 1.9; 2.5; 3.1 units on a scale
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…
Phase 3 N=30 Comparison of Two Urostomy Bags (2-piece).
Urostomy Patent
Primary: Preference of the Two Urostomy Products — 21; 4 participants
N/A N=26 Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
Ileostomy - Stoma
Primary: Degree of Leakage — 4.5; 5.2; 6.4; 6.8 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=216 Ostomy Telehealth For Cancer Survivors
Colostomy Stoma
Primary: Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. — 66.9; 64.2; 67.6; 66.2 score on a scale — p=0.06
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=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
N/A N=170 The Advocate Study
Ostomy
Primary: Stoma Related Cost of Care — 223.73; 260.19 USD
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=52 Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
Obstructed Defecation Syndrome · Rectocele · Intussusception
Primary: Quality of Life — 3.2; 3.7; 2.8; 3.3 units on a scale — p=0.1340
N/A N=64 Safety and Performance of New 1-piece Ostomy Product
Stoma Ileostomy
Primary: Degree of Leakage — 50; 44; 41; 60 percentage of baseplates with no leakage
N/A N=20 Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
Stoma - Ileostomy
Primary: Degree of Leakage — 5.0; 5.6 units on a scale
Phase 1 N=12 Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
C. Diff. Infections
Primary: Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation — 0; 0; 0; 0 Participants
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=74 A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Ileostomy - Stoma · Colostomy
Primary: Leakage Under the Baseplate (cm^2) — 9.2; 6.6 cm2
N/A N=29 Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Subjects With an Ileostomy
Primary: Degree of Leakage — 1.8; 1.8; 1.9; 1.7 units on a scale
N/A N=31 Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
Ileostomy - Stoma · Colostomy - Stoma
Primary: Degree of Leakage — 3.5; 3.1 units on a scale
Phase 2 N=11 A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
Healthy Volunteers
Primary: Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004. — 137,800.0; 178,600.0; 143,800.0; 169,200.0 ng/mL