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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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=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 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=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
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=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
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
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=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
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=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=11 Clinical Investigation Exploring Two Ostomy Product Prototypes
Stoma Ileostomy
Primary: Primary Objective — 7; 4; 1; 4 Participants
Phase 1 N=21 Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
Healthy Adults
Primary: To Evaluate the Effect of BSS on the Human Gut Microbiome. — 2 Number of different bacterial taxa — p=<0.05
Phase 1 N=20 Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Inflammatory Bowel Disease (IBD)
Primary: Clinical Response — 9 Participants — p=0.03
N/A N=46 Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Inflammatory Bowel Disease (IBD) · Ulcerative Colitis (UC) · Crohn's Disease (CD)
Primary: Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types — 41; 16; 25 participants
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=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=83 A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
Peristomal Skin Complication
Primary: The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3) — 1.8; 2.0 score on a scale — p==0.015
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
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=9 Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Compliance, Patient
Primary: Urine Flow Rate — 5.43; 5.47; 2.88 mL per second
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=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…
Phase 1 N=76 Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.
Healthy Volunteer Study
Primary: Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A) — 0; 0; 0; 0 score on a scale (change)
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=30 Investigation of New Intermittent Catheters in Healthy Volunteers
Retention, Urinary
Primary: Residual Urine at 1st Flow-stop — 35.0; 1.1; 0.2; 37.0 mL — p=0.010
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