Investigation of the Performance of Ostomy Base Plate

NCT01103466 | Completed Results

• 1 other identifier: CP204OC
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.

Conditions

Ileostomy - Stoma

Keywords

Ileostomy base plate

Outcome Measures

Primary Outcomes (1)

• Leakage Under the Base Plate

  Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.

  At every change of base plate

Study Arms (3)

New ostomy appliance (Atlas)

ACTIVE COMPARATOR

Atlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names

Device: Atlas

SenSura

ACTIVE COMPARATOR

Commercially available ostomy appliance

Device: SenSura

Conform 2

ACTIVE COMPARATOR

Commercially available ostomy appliance

Device: Conform 2

Interventions

Atlas DEVICE

Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

Also known as: ostomy appliance

New ostomy appliance (Atlas)

SenSura DEVICE

SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

Also known as: ostomy appliance

SenSura

Conform 2 DEVICE

Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

Also known as: Ostomy appliance

Conform 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written Informed Consent
• Are at least 18 years old
• Had their ileostomy for minimum 3 months with a size between 20-40 mm
• Have mental capacity to understand study guidelines and questionnaires
• Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
• Experience leakage under the base plate at least one a week
• Are currently using a flat 2-piece base plate with mechanical coupling
• Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study

You may not qualify if:

• Pregnant or breast-feeding
• Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy
• Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
• Currently using a convex system
• Participating in other clinical studies or have previously participated in this study

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Results Point of Contact

• Title: Dr. Lis Hentze Poulsen
• Organization: Coloplast A/S

dklhp@coloplast.com

4549111111

Study Officials

• Lis H Poulsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 4, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-02

Locations

DK (1)