Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

NCT ID: NCT03770078

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2019-03-06

Brief Summary

The study investigates the performance of a new adhesive with regard to the skin condition

Conditions

Ileostomy - Stoma; Colostomy Stoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study period

First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)

Group Type: EXPERIMENTAL

Test Product A

Intervention Type: DEVICE

The test product is a newly developed ostomy product

Interventions

Test Product A

The test product is a newly developed ostomy product

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have given written informed consent
• Have an ileostomy or a colostomy with liquid* output (as their usual output)
• Be at least 18 years of age and have full legal capacity
• Have had their stoma for at least three months
• Be able to use products with max cut size 45 mm
• Have self-reported problems with leakage** (three times within 14 days)
• Handle the Clinical App, test product and comparator product themselves
• Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
• Minimum change of baseplate at least once every 3rd day
• Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
• Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion Criteria

• Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
• Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
• Are breast feeding
• Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

• Have known hypersensitivity towards any of the products used in the investigation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birte P Jakobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

CCBR Aalborg

Aalborg, , Denmark

Coloplast

Humlebæk, , Denmark

CCBR Vejle

Vejle, , Denmark

KTA Prim Stockholm

Stockholm, , Sweden

Countries

Denmark; Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP300

Identifier Type: -

Identifier Source: org_study_id