At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 122 enrolled

Drug / intervention

SenSura Mio +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01513330

NCT01513330Phase 4Completed

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An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

Coloplast A/S·interventional·Posted Jan 20, 2012·Updated Jan 9, 2014

In Brief

A Phase 4 clinical trial evaluating SenSura Mio and Standard Care for Stoma Colostomy. Completed, enrolled 122 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStoma Colostomy

CountriesGermany

Collaborators--

Timeline

Phase 4CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2011

First PostedJan 2012

Primary CompletionJun 2012

Study CompletionAug 2012

TodayJul 2026

First PostedJan 20, 2012

Enrollment StartNov 1, 2011

Primary CompletionJun 1, 2012

Study CompletionAug 1, 2012

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 14.5 years ago

Interventions

SenSura Miodevice

Ostomy product - 1 piece closed bag

Standard Caredevice

Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.