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Performance Study of Newly Developed Ostomy Products

NCT01513330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-01-09

Study results available
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Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Conditions

  • Stoma Colostomy

Interventions

DEVICE

SenSura Mio

Ostomy product - 1 piece closed bag

DEVICE

Standard Care

Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Wenche Sundberg, stoma nurse · Diakonhjemmet Sykhus, Oslo

  • Merete Bjørke, Stoma Nurse · St. Olavs Hopsital

  • Vigids Dagsland, Stoma Nurse · Haugesund Sykhus

  • Randi Melum, Stoma Nurse · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • Germany

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 NCT01513330 on ClinicalTrials.gov