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.
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=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=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
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 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=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=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=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=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=24 SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
Colorectal Cancer
Primary: Migration — 2 Participants
N/A N=11 The Cascade Feasibility Pilot (Ileostomy)
Ileostomy; Complications · Ileostomy - Stoma
Primary: Attrition Rate — 2 Participants
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…
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
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=7 A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
Constipation · Fecal Incontinence · Spinal Cord Injury
Primary: Change in Bowel QoL — -4.17; -3.65 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
Phase 4 N=62 NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Colonic Neoplasms · Rectal Neoplasms · Diverticulitis
Primary: Anastomotic Leakage — 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…
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
Phase 4 N=120 Sugammadex To IMprove Bowel Function
Bowel Dysfunction · Postoperative Complications · Neuromuscular Blockade
Primary: Gastric Emptying — 1120; 1130 log(ng*ml-1)*min — p=0.58
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=75 Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Obstructive Defecation Syndrome · Chronic Constipation · Rectocele
Primary: Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure — 60.8 percentage of change
N/A N=130 Comparison Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy
Anastomosis
Primary: Cumulative Recovery Rate — 100; 100 percentage of 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=7 Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
Polyps
Primary: Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) — 6 participants
N/A N=22 Human Skin Test Model in Colostomists
Colostomy Stoma
Primary: Peel Force — 2.6; 2.1; 4.4; 3.4 Newton
N/A N=170 The Advocate Study
Ostomy
Primary: Stoma Related Cost of Care — 223.73; 260.19 USD