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Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma | Clinical Trials | Clareo Health

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

NCT03770078•Coloplast A/S

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (4)

CCBR Aalborg

Aalborg, Denmark

Coloplast

Humlebæk, Denmark

CCBR Vejle

Vejle, Denmark

KTA Prim Stockholm

Stockholm, Sweden

Key Dates

Start Date

November 12, 2018

Primary Completion Date

March 6, 2019

Completion Date

March 6, 2019

Last Updated

April 1, 2025

Enrollment

ACTUAL participants

Conditions

Ileostomy - StomaColostomy Stoma

Interventions

Test Product A

DEVICE

Magnesium in Gastrointestinal Disease

NCT07338565

Colitis UlcerosaColitis Ulcerative+10 more

View study

RECRUITING

Impact on the Absorption of Drugs in Ostomy Patients

NCT07138326

Stoma IleostomyIleostomy - Stoma+3 more

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: April 1, 2025Data 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.

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

Inclusion Criteria

Exclusion Criteria

Magnesium in Gastrointestinal Disease

Impact on the Absorption of Drugs in Ostomy Patients

Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

Chyme Reinfusion for Type 2 Intestinal Failure

Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

The Cascade Feasibility Pilot (Ileostomy)