Investigation of a New 1-piece Convex Ostomy Product

Stoma Ileostomy Clinical Trial

Official title:

Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043782
• Other study ID #: CP241
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: November 4, 2015
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: November 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are at least 18 years of age and have full legal capacity.

• Have had an ileostomy/colostomy for more than 3 months

• Have used a 1-piece flat ostomy product for the last 1 month

• Has given written Informed Consent and signed the letter of authority

• Have an ileostomy or colostomy with a diameter of 33 mm or less

• 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

• If having a colostomy: changes their product on average 2 times pr. 24h or more

• Currently uses a bag of size medi/midi or maxi

Exclusion Criteria:

• Have a loop ostomy (also called double-barrel or ostomy with two outlets).

• Are pregnant or breastfeeding

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy

• Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area

• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).

• Known hypersensitivity toward any of the test products

• Participating in other interventional clinical investigations or have previously participated in this investigation

• Use irrigation during the investigation (flush the intestine with water)

• Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate

• If subject has a colostomy: empties the bag

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stoma Colostomy
• Stoma Ileostomy

Intervention

Device:
• Coloplast Test
Newly developed 1-piece convex ostomy product
• Own product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
• Competitor soft convex
A commercially available soft convex product

Locations

Country	Name	City	State
Denmark	TFS	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Leakage	The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.	14 +/- 3 days	No