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

NCT02517541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-11-16

Study results available
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Summary

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

Conditions

  • Ileostomy - Stoma
  • Colostomy

Interventions

DEVICE

SenSura Mio Convex Soft

SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Camilla F Vibjerg, M.Sc.pharm · Head of Clinical Operations

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02517541 on ClinicalTrials.gov