An Investigation of Ostomy Devices

NCT01514136 | Completed Results

• 1 other identifier: CP216
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ileostomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

One arm

EXPERIMENTAL

The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A\*, B\*, C\*, D\*.

Device: Ostomy appliance: convex 1-piece drainable

Interventions

Ostomy appliance: convex 1-piece drainable DEVICE

8 variations of an ostomy devices are tested

One arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, Denmark, 3050, Denmark

Location

Limitations and Caveats

This was an exploratory investigation where the participating subjects had to test 8 different test products. A small number of subjects were analysed from two different populations (convex product/flat product users).

Results Point of Contact

• Title: Birte Petersen Jakobsen, MD
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1990

Study Officials

• Birte P Jakobsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 20, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 11, 2015
• Results First Posted: January 29, 2015

Record last verified: 2015-02

Locations

DK (1)