Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast test product; Device: SenSura

Detailed Description

The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Hospital Bonheiden
• Denmark
  • Aabenraa, Denmark, 6200
    • Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland
  • Humlebæk, Denmark, 3050
    • Coloplast A/S
  • Kolding, Denmark, 6000
    • Stomiambulatoriet, Kolding Sygehus
  • Odense C, Denmark, 5000
    • Stomiambulatoriet A5, Odense Hospital
  • Svenborg, Denmark, 5700
    • Kirurgisk ambulatorium/Stomiambulatoriet OUH
  • Vejle, Denmark, 7100
    • Vejle Sygehus, Stomiambulatoriet B120
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • QPS Netherlands
• Norway
  • Haugesund, Norway, 5504
    • Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus
  • Larvik, Norway, 3269
    • Helse Nordbyen
• Sweden
  • Gävle, Sweden, 801 87
    • Länssjukhhuset gävle, Stomimottagningen
  • Karlstad, Sweden, 651 85
    • Kirug kliniken Centralsjukhuset
  • Malmö, Sweden, 205 02
    • Kirurgens Mottagning
  • Stockholm, Sweden, 112 45
    • Capio St. Görans Sjukhus AB, kirurgkliniken
  • Stockholm, Sweden, 117 61
    • Södersjukhuset
  • Stockholm, Sweden, 171 76
    • karolinska Universitetssjukhuset Solna Stomimottagningen
  • Västerås, Sweden, 721 89
    • Stomimottagningen Centrllasarette i Västerås

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1.Have given written informed consent and letter of authority (DK only)
• 2.Be at least 18 years of age and have full legal capacity.
• 3.Be able to handle the products her/himself
• 4.Have an ileostomy with a diameter between 10 and 40 mm.
• 5.Have had their ostomy for at least three months.
• 6.Be willing to use minimum 2 base plates every week
• 7.Currently use 2-piece flat mechanical coupling product with open bag 8
• 11.Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

• 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• 3.Is pregnant or breastfeeding.
• 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
• 5.Has participated in the previous explorative study CP234
• 6.
• 7.Known hypersensitivity towards any of the test products
• 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1, First Coloplast Test product; Subjects first allocated to Coloplast Test product will after cross-over test SenSura	Device: Coloplast test product; Coloplast test product is a newly developed 2-piece ostomy appliance; Device: SenSura; SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S; Other Names: SenSura Click; SenSura Standard 2-piece
Experimental: Treatment seqence 2; First SenSura; Subjects first allocated to SenSura will after cross-over test Coloplast Test product	Device: Coloplast test product; Coloplast test product is a newly developed 2-piece ostomy appliance; Device: SenSura; SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S; Other Names: SenSura Click; SenSura Standard 2-piece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference	The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.	21+1 days

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte P Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 1, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 1, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CP243