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Investigation of the Performance of Ostomy Base Plate

NCT01103466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-04-04

Study results available
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Summary

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Atlas

Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

DEVICE

SenSura

SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

DEVICE

Conform 2

Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Lis H Poulsen, MD · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01103466 on ClinicalTrials.gov