# Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

> **NCT01957384** · NA · COMPLETED · sponsor: **Coloplast A/S** · enrollment: 25 (actual)

## Conditions studied

- Ileostomy - Stoma

## Interventions

- **DEVICE:** Coloplast Test product 1
- **DEVICE:** Coloplast Test product 2
- **DEVICE:** Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

## Key facts

- **NCT ID:** NCT01957384
- **Lead sponsor:** Coloplast A/S
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-02
- **Primary completion:** 2012-05
- **Final completion:** 2012-05
- **Target enrollment:** 25 (ACTUAL)
- **Last updated:** 2014-03-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01957384

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01957384, "Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT01957384. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*