A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

NCT02517541 | Completed Results

• 1 other identifier: CP259
• Study Type: interventional
• Target: 74
• Locations: 4 countries
• Sites: 9

Brief Summary

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

Conditions

Ileostomy - Stoma; Colostomy

Outcome Measures

Primary Outcomes (1)

• Leakage Under the Baseplate (cm^2)

  The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.

  14 weeks (2 weeks baseline + 12 weeks intervention)

Study Arms (1)

Test period

EXPERIMENTAL

The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft)

Device: SenSura Mio Convex Soft

Interventions

SenSura Mio Convex Soft DEVICE

SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast

Test period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have an ileostomy or colostomy
• Have had their ostomy for at least 3 months
• Must use 1 piece open or closed ostomy products during the test period
• Currently using a 1 piece. flat product
• Must be able to use custom cut product
• Have intact peristomal skin
• Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
• Are evaluated to be suitable for a soft convex product

You may not qualify if:

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (9)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Prism research center

Saint Paul, Minnesota, 55114, United States

Location

QPS Netherlands

Groningen, 9713, Netherlands

Location

Helse Nordbyen

Larvik, 3269, Norway

Location

Synexus Midlands

Birmingham, B15 2SQ, United Kingdom

Location

Pilgrim Hospital

Boston, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, G1537AN, United Kingdom

Location

Kettering General hospital

Kettering, NN168UZ, United Kingdom

Location

Lincon Country hospital

Lincoln, LN25QY, United Kingdom

Location

Results Point of Contact

• Title: Zenia M Størling
• Organization: Scientific and Regulatory affairs

dkzenst@coloplast.com

+45 49111869

Study Officials

• Camilla F Vibjerg, M.Sc.pharm

  Head of Clinical Operations

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 16, 2022
• Results First Posted: September 6, 2018

Record last verified: 2022-11

Locations

NL (1); GB (5); NO (1); US (2)