Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

NCT01243294 | Completed Phase 2 Results

• 1 other identifier: CP209OC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

Conditions

Colostomy

Outcome Measures

Primary Outcomes (1)

• Leakage (Percent of All Base Plates With Leakage)

  Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point

  After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Secondary Outcomes (5)

• Adverse Events

  During the investigation ~ 24 days per subject

• Security (Subjects Own Assessment)

  After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

• Handling at Appliance (Subjects Own Assessment)

  After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

• Comfort (Subjects Own Assessment)

  After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

• Wear Time (Registered by Subject When Applying and Removing a Product)

  After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Study Arms (2)

SenSura

ACTIVE COMPARATOR

CE marked and launched (The letters "CE" do not represent any specific words, though may have initially stood for "Communauté Européenne" ("European Community") or "Conformité Européenne" ("European Conformity"). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements.

Device: SS; Device: SenSura

New ostomy appliance (SS)

ACTIVE COMPARATOR

SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names.

Device: SS; Device: SenSura

Interventions

SS DEVICE

New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.

Also known as: SenSura, New ostomy appliance

New ostomy appliance (SS); SenSura

SenSura DEVICE

New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.

Also known as: New ostomy appliance

New ostomy appliance (SS); SenSura

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
• Be at least 18 years of age and have full legal capacity
• Be able to handle the bags themselves (application, removal)
• Have a colostomy with a diameter less than 45 mm
• Have had a colostomy for at least 3 months
• Currently use a 1-piece flat ostomy appliance with closed bag
• is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
• Use minimum 1 product per day
• Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
• Have the mental capacity to understand the study and questionnaires

You may not qualify if:

• Use irrigation during the study (flush the stoma with water).
• Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
• Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
• Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
• Are pregnant or breastfeeding

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Pia Nordmand, Clinical Trial Manager
• Organization: Coloplast A/S

dkpialn@coloplast.com

+4549113250

Study Officials

• Pia Nordmand, MSc

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: November 18, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 7, 2011
• Results First Posted: June 22, 2011

Record last verified: 2011-10

Locations

DK (1)