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Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

NCT02887144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-09-02

No results posted yet for this study

Summary

The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Conditions

  • Stoma Ileostomy

Interventions

DEVICE

SenSura

SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S

DEVICE

SenSura test product

SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Denmark

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 NCT02887144 on ClinicalTrials.gov