An interventional study of SenSura and Morfeus in Ileostomy - Stoma, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-31.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
The aim of the current clinical investigation is to evaluate a new filter
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
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:
SenSura is the reference product and the product is already commercially available
Device: SenSura
The test product is the product with the proposed new filter (Morfeus)
Device: Morfeus
The ostomy bag filter will be tested for a period of 14 days
The new ostomy bag filter will be tested for a period of 14 days
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.
Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
Time frame: Daily or at every change of bag in a period of a maximum of 28 days
The subjects were recruited from a user data base in Denmark.
| Milestone | Sensura First; Then Morfeus | Morfeus First; Then Sensura |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Sensura First; Then Morfeus | Morfeus First; Then Sensura |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 10 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
| percentage bags with ballooning | Sensura | Morfeus |
|---|---|---|
| Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | 55 | 26 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sensura | — | 1/20 (5%) | 3/20 (15%) |
| Morfeus | — | 0/20 (0%) | 0/20 (0%) |
| Event | Sensura | Morfeus |
|---|---|---|
| Abscess in the buttockMusculoskeletal and connective tissue disorders | 1/20 | 0/20 |
| Event | Sensura | Morfeus |
|---|---|---|
| Pristomal skin rednessSkin and subcutaneous tissue disorders | 2/20 | 0/20 |
| Sleep disruptionNervous system disorders | 1/20 | 0/20 |
| Age Continuous(years) | Sensura | Morfeus | Total |
|---|---|---|---|
| Mean | 59 ± 13 | 61 ± 10 | 60 ± 11 |
| Sex: Female, Male(Participants) | Sensura | Morfeus | Total |
|---|---|---|---|
| Female | 6 | 1 | 7 |
| Male | 4 | 9 | 13 |
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Coloplast A/S