An interventional study of New 2-piece Coupling and SenSura Mio Click in Surgical Stomas, sponsored by Coloplast A/S. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Prevention
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
It will be a 1:1 randomization into the two possible treatment sequences
Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days).
All visits will be performed as remote virtual calls. At the visits, the investigator will give instructions for the coming period and check that the trial is running as planned. At every bag change the subject will be asked to complete a questionnaire.
A follow-up call will be scheduled 7±1 days after each test visit to ensure compliance with the provided product and study procedures. Additional calls may be scheduled if needed.
Minimum 40 participants will be enrolled and randomized.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray
The arm includes the new 2-piece coupling
Device: New 2-piece Coupling
The arm includes the existing 2-piece coupling
Device: SenSura Mio Click
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.
Leakage Through Coupling Registered at Each Bag Change (Yes/no)
Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
Time frame: 3 weeks
How Satisfied Are You With the New Coupling?
Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied)
Time frame: 3 weeks - evaluated at the end of the study
Would You Consider Using the New Coupling in the Future?
Preference evaluated at end of the investigation by the question "Would you consider using the new coupling in the future?" (Yes/No)
Time frame: Based on 3 weeks - evaluated at the end of the study period
First Patient In: 15 Feb 2023 Last Patient Out: 17 July 2023
| Milestone | New Coupling First, Then Comparator Device | Comparator Device First, Then New Coupling |
|---|---|---|
| Started | 22 | 25 |
| Completed | 22 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | New Coupling First, Then Comparator Device | Comparator Device First, Then New Coupling |
|---|---|---|
| Started | 22 | 24 |
| Completed | 21 | 24 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
| Proportion of bag changes/participant | New Coupling | Comparator Device |
|---|---|---|
| Leakage Through Coupling Registered at Each Bag Change (Yes/no) | 0.151 (0.089 to 0.247) | 0.237 (0.156 to 0.341) |
Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied)
| Participants | Very Satisfied / Satisfied | Dissatisfied / Very Dissatisfied |
|---|---|---|
| How Satisfied Are You With the New Coupling? | 35 | 4 |
Preference evaluated at end of the investigation by the question "Would you consider using the new coupling in the future?" (Yes/No)
| Participants | Would Consider Using the New Coupling in the Future: Yes | Would Consider Using the New Coupling in the Future: No |
|---|---|---|
| Would You Consider Using the New Coupling in the Future? | 32 | 7 |
Leakage from coupling, visible outside coupling on baseplate when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
| Proportion of bag changes/participant | New Coupling | Comparator Device |
|---|---|---|
| Leakage Visible Outside the Coupling | 0.012 (0.004 to 0.032) | 0.044 (0.024 to 0.082) |
Collected over Adverse events were collected over the study period of 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New Coupling | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Comparator Device | 0/47 (0%) | 0/47 (0%) | 1/47 (2.1%) |
| Event | New Coupling | Comparator Device |
|---|---|---|
| Skin breakdown around peristomal areaSkin and subcutaneous tissue disorders | 0/47 | 1/47 |
Demographics are described for the total ITT population
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 55.6 ± 13.3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 18 |
| Male | 29 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Stoma type(Participants) | All Participants |
|---|---|
| Colostomy | 19 |
| Ileostomy | 28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Coloplast A/S