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Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin

NCT01245413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-01-01

Study results available
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Summary

Aim

The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.

The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products.

Success criteria:

The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.

Design:

Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities.

Population:

The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike.

The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.

Conditions

  • Healthy

Interventions

DEVICE

SenSura

Adhesive to stoma bag

DEVICE

Athena

Adhesive to stoma bag

Sponsors & Collaborators

  • Lægernes Test Center A/S

    collaborator UNKNOWN

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Claus Hyldahl, MD · Lægehuset

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2010-11-30
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 NCT01245413 on ClinicalTrials.gov