N/A N=74 Basic Science

A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Ileostomy - Stoma · Colostomy

Bottom Line

View on ClinicalTrials.gov: NCT02517541 ↗

Enrolled (actual)

Serious AEs

0.7%

Results posted

Sep 2018

Primary outcome: Primary: Leakage Under the Baseplate (cm^2) — 9.2; 6.6 cm2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SenSura Mio Convex Soft (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Leakage Under the Baseplate (cm^2)	9.2; 6.6	—

Summary

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

Eligibility Criteria

Inclusion Criteria

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have an ileostomy or colostomy
Have had their ostomy for at least 3 months
Must use 1 piece open or closed ostomy products during the test period
Currently using a 1 piece. flat product
Must be able to use custom cut product
Have intact peristomal skin
Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
Are evaluated to be suitable for a soft convex product

Exclusion Criteria

Currently receiving or have within the past 2 month received radio- and/or chemotherapy
Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
Are pregnant or breastfeeding
Participating in other interventional clinical investigations or have previously participated in this investigation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02517541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.