Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

Stoma Ileostomy Clinical Trial

Official title:

Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994902
• Other study ID #: CP232
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: December 8, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Are at least 18 years of age and have full legal capacity.

2. Has had an ileostomy for at least 3 months.

3. Has used a convex ostomy product for the last month.

4. Has given signed informed consent.

5. Has experienced seeping under the baseplate at least three times during the last two weeks.

6. Currently using a SenSura Convex product with midi, maxi or magnum bags.

7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").

8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria:

1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).

2. Are pregnant or breastfeeding.

3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.

4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.

5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.

6. Are currently participating in another clinical intervention study or have previously participated in this one.

7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.

8. Has known hypersensitivity toward the test product.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
• SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.

Locations

Country	Name	City	State
Denmark	TFS	Søborg
France	Hopital du bocage	Dijon cedex
France	Hopital Robert Boulin	Libourne cedex
France	Hopital Claude Huriez	Lille cedex
France	Hopital Nord	Marseille
France	Hopital Cochin	Paris
France	Hopital Tenon	Paris
France	Hopital de Haut Levêque	Pessac cedex
France	CHRU La Milétrie	Poitiers Cedex
Germany	BB medica medizinisches	Aachen
Germany	Sanitätshause reinhold hilscher e.K.	Augsburg
Germany	Patientenberatung Strack e.K.	Bad Staffelstein
Germany	Pro-samed Santitätshaus	Berlin
Germany	SIEWA coloplast Homecare	Burgdorf
Germany	SIEWA Coloplast Homecare	Freising
Germany	SIEWA Coloplast homecare	Leinfelden-echterdingen
Germany	Schürmaier GmbH &Co	Leipzig
Germany	Sanitätshaus Fürst GmbH	Passau
Germany	SIEWA Coloplast Homecare	Saulgrub
Germany	Sanitäts- und gesundheitshaus Carqueville GmbH	Töppeln
Germany	Alippi GmbH	Zwickau
Norway	Sykpleierklinikken	Larvik
United Kingdom	Pilgrim Hospital	Boston
United Kingdom	Addenbrookes	Cambridge
United Kingdom	Cheltenham General Hospital	Gloucestershire
United Kingdom	Lincon Country hospital	Lincoln
United Kingdom	Charing Cross Hospital	London
United Kingdom	Kettering General hospital	Northamptonshire
United Kingdom	west Suffolk Hospital	Suffolk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Leakage	The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).	28 +/- 3 days	No