Safety and Performance of New 1-piece Ostomy Product

NCT01800916 | Completed Results

• 1 other identifier: CP236
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Conditions

Stoma Ileostomy

Keywords

ileostomy; Subjects

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage

  one week

Study Arms (3)

Treatment sequence 1

EXPERIMENTAL

The subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB

Device: Coloplast Adhesive baseplate A; Device: Coloplast Adhesive baseplate B; Device: SenSura 1-Piece

Treatment sequence 2

EXPERIMENTAL

The subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB

Device: Coloplast Adhesive baseplate B; Device: Coloplast Adhesive baseplate C; Device: SenSura 1-Piece

Treatment sequence 3

EXPERIMENTAL

The subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC

Device: Coloplast Adhesive baseplate A; Device: Coloplast Adhesive baseplate C; Device: SenSura 1-Piece

Interventions

Coloplast Adhesive baseplate A DEVICE

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.

Treatment sequence 1; Treatment sequence 3

Coloplast Adhesive baseplate B DEVICE

Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance

Treatment sequence 1; Treatment sequence 2

Coloplast Adhesive baseplate C DEVICE

Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

Treatment sequence 2; Treatment sequence 3

SenSura 1-Piece DEVICE

SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3

Eligibility Criteria

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

You may qualify if:

• Have given written informed consent and signed letter of authority form.
• Be at least 18 years of age and have full legal capacity.
• Be able to handle the bags themselves.
• Have an ileostomy with a diameter between 15 and 40 mm.
• Have had their ostomy for at least three months.
• Currently use a 1-piece flat ostomy appliance with open bag.
• Use minimum 1 ostomy appliance every second day.
• Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
• Must be able to use a custom cut ostomy appliance.
• Accept to test three 1-piece ostomy appliances in the investigation.
• Negative result of a pregnancy test for women of childbearing age (only DK).

You may not qualify if:

• Use irrigation during the study (flush the stoma with water).
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
• Are pregnant or breastfeeding.
• Participating in other interventional clinical investigations or have previously participated in this investigation.
• Currently using ostomy belt.
• Currently using extended wear product.
• Known hypersensitivity towards any of the test products
• 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)

Holtedam 3

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Marian Sinvani
• Organization: Coloplast A/S

dkmards@coloplast.com

+45 49112356

Study Officials

• Birte Jakobsen, Dr.

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 28, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 14, 2017
• Results First Posted: May 30, 2014

Record last verified: 2017-03

Locations

DK (1)