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NCT03427203
Assessment of New Ostomy Devices in Subjects Having an Ileostomy
NA trial testing SenSura Mio in Ileostomy - Stoma in 35 participants. Completed in 6 April 2018.
6 April 2018
Quick facts
| Lead sponsor | Coloplast A/S |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 35 |
| Start date | 9 January 2018 |
| Primary completion | 6 April 2018 |
| Estimated completion | 6 April 2018 |
| Sites | 3 locations across Denmark, Netherlands |
Drugs / interventions tested
- SenSura Mio
- Coloplast Ostomy device 1
- Coloplast Ostomy device
- Coloplast Ostomy device 3
Conditions studied
- Ileostomy - Stoma — all drugs for Ileostomy - Stoma →
Sponsor
Coloplast A/S — full company profile →
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 study investigates the performance of three new adhesives with regard to leakage and the skin condition.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical Measurement of Transepidermal Water Loss.
Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148
Verify or expand the search:
- PubMed search for NCT03427203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ileostomy - Stoma
Currently open trials in the same condition.
- NCT06737887 — The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation · NA · recruiting
- NCT07464548 — Effects of Stoma Education on Patients · NA · recruiting
- NCT07338565 — Magnesium in Gastrointestinal Disease · recruiting
- NCT07138326 — Impact on the Absorption of Drugs in Ostomy Patients · recruiting
- NCT06824623 — Readmission and Dehydration Prevention in Patients With Elective Ileostomy · recruiting
Other Coloplast A/S trials
Trials by the same sponsor.
- NCT07475468 — CP382 - Intermittent Catheter (IC) PRO Panel Plan · not yet recruiting
- NCT07384559 — Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injur · NA · not yet recruiting
- NCT07376421 — Clinical Investigation Exploring a Newly Developed Ostomy Baseplate · NA · recruiting
- NCT07126327 — Peristeen Light Explorative Clinical Investigation · NA · recruiting
- NCT07316530 — Clinical Investigation Exploring a Newly Developed Ostomy Baseplate. · NA · completed
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 NCT03427203 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Coloplast A/S
- Last refreshed: 6 June 2018
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/NCT03427203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing