Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy (CP257)

August 29, 2016 updated by: Coloplast A/S
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

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

  • Denmark
      • Humlebaek, Denmark, 3050
        • Coloplast A/S

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:

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Be able to handle the products themselves
  4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
  5. Have had their ileostomy for at least 3 months
  6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
  7. Currently using midi or maxi bags
  8. Willing to use minimum 1 product every second day (max. 2 days wear time)
  9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
  10. Must be able to cut products themselves

Exclusion Criteria:

  1. Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
  2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
  3. Are pregnant or breastfeeding
  4. Participating in other interventional clinical investigations or have previously participated in this investigation
  5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
  6. Known hypersensitivity of the product components and/or ingredients

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SenSura test product 1pc

Subjects randomized to treatment sequence 1test:

  1. SenSura test product
  2. SenSura
Device: SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
Device: SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
EXPERIMENTAL: SenSura 1pc

Subjects randomized to treatment sequence 2 test:

  1. SenSura
  2. SunSura test product
Device: SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
Device: SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of leakage
Time Frame: patients will test the products for 4 weeks
Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.
patients will test the products for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

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

January 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

August 29, 2016

First Posted (ESTIMATE)

September 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Coloplast - CP257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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