Loading clinical trials...

COMPLETEDNA

The Influence of Adhesive Wafer Design on Fit to the Body

NCT02176954•Coloplast A/S

Summary

The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
•Have given written informed consent and signed letter of Authority
•Be at least 18 years of age and have full legal capacity
•Have had their ileostomy or colostomy for at least 3 months
•Have a stoma with a diameter between 15 and 43 mm
•Be able to handle the product themselves
•Be able to use a custom cut product
•Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
•Currently using a 1-piece flat product or a 1-piece soft convex product
•Be willing to test products with open bag size maxi
+4 more criteria

Exclusion Criteria

•Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
•Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
•Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
•Are pregnant or breastfeeding
•Are participating in other interventional clinical investigations or have previously participated in this investigation
•Use irrigation during the investigation (flush the intestines with water)
•Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
•Have a loop stoma
•Have known hypersensitivity towards any of the test products

Locations (10)

QPS Netherlands

Groningen, Netherlands

Synexus Thames Valley

Berkshire, United Kingdom

Synexus Midlands

Birmingham, United Kingdom

Synexus Wales

Cardiff, United Kingdom

Synexus Scotland

Glasgow, United Kingdom

Cheltenham General Hospital

Gloucestershire, United Kingdom

Synesxus Lancashire

Lancashire, United Kingdom

Synexus Merseyside

Liverpool, United Kingdom

Synexus Manchester

Manchester, United Kingdom

Synexus North East

Northumberland, United Kingdom

Key Dates

Start Date

July 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

March 1, 2015

Last Updated

March 23, 2015

Enrollment

ACTUAL participants

Conditions

Ostomy - Ileostomy or Colostomy

Interventions

Test A

DEVICE

Test B

DEVICE

Comparator

DEVICE

Improving Outcomes of Older Adults Undergoing Ostomy Surgery

NCT07424586

Ostomy - Ileostomy or Colostomy

View study

NOT_YET_RECRUITING

Ostomy Readmission Reduction Program

NCT06956274

Ostomy - Ileostomy or Colostomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions