An Investigation of Ostomy Devices

Ileostomy Clinical Trial

Official title:

CP216: An Exploratory Investigation of Convex Ostomy Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514136
• Other study ID #: CP216
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: February 20, 2015
• Start date: September 2011
• Est. completion date: January 2012

Study information

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

Clinical Trial Summary

Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years old

• Have signed the declaration of informed consent

• Have an ileostomy in a concave area

• Have had an ileostomy for at least three months

• Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month

• Be users of 1-piece or 2-piece open ostomy devices

• Have an ileostomy with a diameter of less than 33 mm

Exclusion Criteria:

• Are pregnant or breast-feeding

• Have a double-loop ileostomy

• Have known hypersensitivity or allergy to the devices' component ingredients

• Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.

• Are receiving/have received local peristomal or systemic steroid treatment within the last month

• Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ileostomy

Intervention

Device:
• Ostomy appliance: convex 1-piece drainable
8 variations of an ostomy devices are tested

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

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 under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.; The scale was developed by Coloplast A/S	One week	No