A Phase 2 interventional study of Coloplast Test product and Standard Care in Ileostomy - Stoma, sponsored by Coloplast A/S. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-11.
Sponsored by Coloplast A/S · Phase 2, Interventional, and Prevention
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
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:
The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.
Device: Coloplast Test product · Device: Standard Care
The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.
Device: Coloplast Test product · Device: Standard Care
Coloplast test product is a newly developed 1-piece ostomy appliance
Also known as: Coloplast 1-piece test product
Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Also known as: Coloplast SenSura, Hollister Moderma/Moderma Flex, B.Braun Flexima/Softima
Leakage
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Time frame: 14+/-3 days per product
| Milestone | First Coloplast Test Product; Then Standard Care (See Below) | First Standard Care (See Below); Then Coloplast Test Product |
|---|---|---|
| Started | 11 | 12 |
| Completed | 4 | 9 |
| Not completed | 7 | 3 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Trial stopped by sponsor | 1 | 3 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Milestone | First Coloplast Test Product; Then Standard Care (See Below) | First Standard Care (See Below); Then Coloplast Test Product |
|---|---|---|
| Started | 8 | 9 |
| Completed | 7 | 5 |
| Not completed | 1 | 4 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
| percentage of baseplates with no leakage | Coloplast Test Product | Standard Care |
|---|---|---|
| Leakage | 50 | 77 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coloplast Test Product | — | 0/20 (0%) | 8/20 (40%) |
| Standard Care | — | 0/20 (0%) | 6/20 (30%) |
| Event | Coloplast Test Product | Standard Care |
|---|---|---|
| Peristomal skin problem/pain/itchingSkin and subcutaneous tissue disorders | 8/20 | 6/20 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 57.2 ± 12.9 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 10 |
| Male | 13 |
| Region of Enrollment(participants) | All Subjects |
|---|---|
| Netherlands | 17 |
| France | 6 |
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Coloplast A/S