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Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

NCT01799239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-09-30

Study results available
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Summary

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Test product

The test product consists of an adhesive with a new top film

DEVICE

SenSura

SenSura is the CE-marked and commercially available comparator product

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Carter, MSc · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Sweden

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 NCT01799239 on ClinicalTrials.gov