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NCT06897163
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
NA trial testing Specialized Absorbent Intestinal Tampon in Ileostomy - Stoma in 10 participants. Completed in 31 August 2025.
31 July 2025
Quick facts
| Lead sponsor | Ampa Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 10 December 2024 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Specialized Absorbent Intestinal Tampon
Conditions studied
- Ileostomy - Stoma — all drugs for Ileostomy - Stoma →
Sponsor
Ampa Medical
Who can join
18 and older, any sex, with Ileostomy - Stoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output. The main questions it aims to answer are: * Can participants successfully self-insert the intestinal tampon? * What is the level of discomfort or pain associated with the insertion and use of the tampon? Researchers will compare different tampon designs and coatings to find the most suitable one for insertion and retention. Participants will: * Be observed and interviewed during the insertion of the tampon by a medical consultant. * Self-insert the tampon under supervision and later independently. * Provide feedback on their experience, including any discomfort or pain using a numerical rating scale (NRS). * Provide stool samples before and after using the tampon for microbiome analysis. This study aims to determine the feasibility and user acceptance of the intestinal tampon as an alternative to traditional stoma bags, potentially reducing complications and improving the quality of life for people with an ileostomy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06897163
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06824623 — Readmission and Dehydration Prevention in Patients With Elective Ileostomy · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06897163 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ampa Medical
- Last refreshed: 5 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06897163.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing