# Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy

> **NCT01448629** · NA · WITHDRAWN · sponsor: **Coloplast A/S**

## Conditions studied

- Leakage
- Skin Condition

## Interventions

- **DEVICE:** Standard Care
- **DEVICE:** River

## Key facts

- **NCT ID:** NCT01448629
- **Lead sponsor:** Coloplast A/S
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2011-05
- **Primary completion:** 2011-07
- **Final completion:** 2011-07
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** The study was withdrawn because of problems found with the baseplate
- **Last updated:** 2012-02-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01448629

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01448629, "Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01448629. Licensed CC0.

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