Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

NCT01994902 | Completed Results

• 1 other identifier: CP232
• Study Type: interventional
• Target: 129
• Locations: 5 countries
• Sites: 29

Brief Summary

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

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

First Coloplast test product

EXPERIMENTAL

The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light

Device: Coloplast test product; Device: SenSura Convex Light

First SenSura Convex Light

EXPERIMENTAL

The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product

Device: Coloplast test product; Device: SenSura Convex Light

Interventions

Coloplast test product DEVICE

The Coloplast test product is a newly developed ostomy appliance

First Coloplast test product; First SenSura Convex Light

SenSura Convex Light DEVICE

The comparator product is SenSura Convex Light, which is CE-marked and commercially available.

Also known as: SenSura

First Coloplast test product; First SenSura Convex Light

Eligibility Criteria

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

You may qualify if:

• Are at least 18 years of age and have full legal capacity.
• Has had an ileostomy for at least 3 months.
• Has used a convex ostomy product for the last month.
• Has given signed informed consent.
• Has experienced seeping under the baseplate at least three times during the last two weeks.
• Currently using a SenSura Convex product with midi, maxi or magnum bags.
• Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
• 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.

You may not qualify if:

• Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
• Are pregnant or breastfeeding.
• Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
• Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
• Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
• Are currently participating in another clinical intervention study or have previously participated in this one.
• Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
• Has known hypersensitivity toward the test product.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (29)

TFS

Søborg, Denmark

Location

Hopital du bocage

Dijon, 21079, France

Location

Hopital Robert Boulin

Libourne, 33505, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

Hopital Nord

Marseille, 13015, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Tenon

Paris, 75020, France

Location

Hopital de Haut Levêque

Pessac, 33604, France

Location

CHRU La Milétrie

Poitiers, 86021, France

Location

BB medica medizinisches

Aachen, Germany

Location

Sanitätshause reinhold hilscher e.K.

Augsburg, Germany

Location

Patientenberatung Strack e.K.

Bad Staffelstein, Germany

Location

Pro-samed Santitätshaus

Berlin, Germany

Location

SIEWA coloplast Homecare

Burgdorf, Hanover, Germany

Location

SIEWA Coloplast Homecare

Freising, Germany

Location

SIEWA Coloplast homecare

Leinfelden-Echterdingen, Germany

Location

Schürmaier GmbH &Co

Leipzig, Germany

Location

Sanitätshaus Fürst GmbH

Passau, Germany

Location

SIEWA Coloplast Homecare

Saulgrub, Germany

Location

Sanitäts- und gesundheitshaus Carqueville GmbH

Töppeln, Germany

Location

Alippi GmbH

Zwickau, Germany

Location

Sykpleierklinikken

Larvik, Norway

Location

Pilgrim Hospital

Boston, United Kingdom

Location

Addenbrookes

Cambridge, CB20QQ, United Kingdom

Location

Cheltenham General Hospital

Gloucestershire, GL53/AI, United Kingdom

Location

Lincon Country hospital

Lincoln, LN25QY, United Kingdom

Location

Charing Cross Hospital

London, W68RF, United Kingdom

Location

Kettering General hospital

Northamptonshire, NN168UZ, United Kingdom

Location

west Suffolk Hospital

Suffolk, IP332QZ, United Kingdom

Location

Results Point of Contact

• Title: Medical Director
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 49111395

Study Officials

• Daniel Carter

  Coloplast A/S

  STUDY DIRECTOR

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: October 18, 2013
• First Posted: November 26, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 12, 2016
• Results First Posted: January 12, 2016

Record last verified: 2015-12

Locations

FR (8); GB (7); DK (1); DE (12); NO (1)