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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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=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
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=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
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=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=25 An Investigation of Ostomy Devices
Ileostomy
Primary: Degree of Leakage — 4.2; 4.3; 4.4; 4.3 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 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
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=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=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=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=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
N/A N=17 Zinc and Copper Absorption in Neonates With Bilious Losses
Ileostomy
Primary: Zinc Absorption — 10.9 fractional zinc absorption (%)
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
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
Phase 2 N=15 A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
Healthy Volunteers With Ileostomy
Primary: Ceftriaxone Concentration in Intestinal Chyme Period 1 — 0.00; 0.00; 5.60; 150.90 ug/mL
N/A N=11 The Cascade Feasibility Pilot (Ileostomy)
Ileostomy; Complications · Ileostomy - Stoma
Primary: Attrition Rate — 2 Participants
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
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 The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Fecal Incontinence
Primary: Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) — 2.8; 3.3; 1.9; 2.5 score on a scale
N/A N=11 Clinical Investigation Exploring Two Ostomy Product Prototypes
Stoma Ileostomy
Primary: Primary Objective — 7; 4; 1; 4 Participants
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
Phase 2 N=8 FMT in Ulcerative Colitis-Associated Pouchitis
Ulcerative Colitis Associated Pouchitis
Primary: Number of Patients Who Experienced Improvement of Pouchitis Symptoms — 2 Participants
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=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