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The Influence of Baseplate Adhesive on the Degree of Leakage

NCT01995357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-02-03

Study results available
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Summary

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Conditions

  • Colostomy Stoma
  • Ileostomy Stoma

Interventions

DEVICE

Coloplast Test A

Coloplast Test A is a newly developed ostomy appliance

DEVICE

Coloplast Test B

Coloplast Test B is a newly developed ostomy appliance.

DEVICE

Standard product

Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte P Jakobsen, MD · 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
2013-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT01995357 on ClinicalTrials.gov