N/A
N=47
Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Surgical Stomas
Bottom Line
View on ClinicalTrials.gov: NCT05652010 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Leakage Through Coupling Registered at Each Bag Change (Yes/no) — 0.151; 0.237 Proportion of bag changes/participant — p=0.164
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- New 2-piece Coupling (Device); SenSura Mio Click (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage Through Coupling Registered at Each Bag Change (Yes/no) |
0.151; 0.237 | 0.164 |
| SECONDARY How Satisfied Are You With the New Coupling? |
35; 4 | <0.0001 sig |
| SECONDARY Would You Consider Using the New Coupling in the Future? |
32; 7 | <0.0001 sig |
Summary
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
Eligibility Criteria
Inclusion Criteria
- Has given written consent to participate by signing the Informed Consent Signature Form
- Be at least 18 years of age and have full legal capacity
- Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves
- Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale)
- Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size
- Have had their ostomy for at least 90 days
- Be willing to change the bag at least twice per week
- Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation
- Is willing to use 2p maxi open bags during the investigation
Exclusion Criteria
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
- Low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
- Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray
- Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.
- Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
- Is pregnant and/or breast-feeding
- Have a loop ileostomy
- Is currently using convex baseplate
- Has known hypersensitivity towards any of the products used in the investigation
Data sourced from ClinicalTrials.gov (NCT05652010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.