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Safety and Performance of New 1-piece Ostomy Product

NCT01800916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-04-14

Study results available
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Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Conditions

  • Stoma Ileostomy

Interventions

DEVICE

Coloplast Adhesive baseplate A

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.

DEVICE

Coloplast Adhesive baseplate B

Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance

DEVICE

Coloplast Adhesive baseplate C

Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

DEVICE

SenSura 1-Piece

SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Birte Jakobsen, Dr. · 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
2013-05-31
Completion
2013-05-31

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 NCT01800916 on ClinicalTrials.gov