- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513330
Performance Study of Newly Developed Ostomy Products
November 21, 2013 updated by: Coloplast A/S
An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Køln
-
Cologne, Køln, Germany
- Publicare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have given written informed consent.
- Be at least 18 years of age and have full legal capacity.
- Have experienced leakage under the base plate at least once a week over the last two weeks.
- Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
- Have a colostomy with a diameter between 20 and 45 mm.
- Have had their ostomy for at least three months.
- Currently use a 1-piece flat product with closed bag.
- Use minimum 1 product per day.
- Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).
Exclusion Criteria:
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: First Standard Care, then SenSura Mio
Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio
|
Ostomy product - 1 piece closed bag
Ostomy product 1 piece closed bags.
Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
|
Experimental: First SenSura Mio, then Standard Care
Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
|
Ostomy product - 1 piece closed bag
Ostomy product 1 piece closed bags.
Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Time Frame: 14 days
|
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S.
The subjects receive Petri dishes with pre-printed leakage scale on.
The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears.
This is done by ticking of each area on the scale indicating the area of leakage.
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wenche Sundberg, stoma nurse, Diakonhjemmet Sykhus, Oslo
- Principal Investigator: Merete Bjørke, Stoma Nurse, St. Olavs Hopsital
- Principal Investigator: Vigids Dagsland, Stoma Nurse, Haugesund Sykhus
- Principal Investigator: Randi Melum, Stoma Nurse, St. Olavs Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
January 10, 2012
First Submitted That Met QC Criteria
January 16, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 9, 2014
Last Update Submitted That Met QC Criteria
November 21, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- CP219
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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