NCT01957553

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
5 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

October 1, 2013

Results QC Date

August 18, 2014

Last Update Submit

September 1, 2014

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Treatment sequence 1, First Coloplast Test product

EXPERIMENTAL

Subjects first allocated to Coloplast Test product will after cross-over test SenSura

Device: Coloplast test productDevice: SenSura

Treatment seqence 2; First SenSura

EXPERIMENTAL

Subjects first allocated to SenSura will after cross-over test Coloplast Test product

Device: Coloplast test productDevice: SenSura

Interventions

Coloplast test productDEVICE

Coloplast test product is a newly developed 2-piece ostomy appliance

Treatment seqence 2; First SenSuraTreatment sequence 1, First Coloplast Test product
SenSuraDEVICE

SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S

Also known as: SenSura Click, SenSura Standard 2-piece
Treatment seqence 2; First SenSuraTreatment sequence 1, First Coloplast Test product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Imelda Hospital Bonheiden

Bonheiden, 2820, Belgium

Location

Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland

Aabenraa, 6200, Denmark

Location

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Stomiambulatoriet, Kolding Sygehus

Kolding, 6000, Denmark

Location

Stomiambulatoriet A5, Odense Hospital

Odense C, 5000, Denmark

Location

Kirurgisk ambulatorium/Stomiambulatoriet OUH

Svendborg, 5700, Denmark

Location

Vejle Sygehus, Stomiambulatoriet B120

Vejle, 7100, Denmark

Location

QPS Netherlands

Groningen, 9713 GZ, Netherlands

Location

Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus

Haugesund, 5504, Norway

Location

Helse Nordbyen

Larvik, 3269, Norway

Location

Länssjukhhuset gävle, Stomimottagningen

Gävle, 801 87, Sweden

Location

Kirug kliniken Centralsjukhuset

Karlstad, 651 85, Sweden

Location

Kirurgens Mottagning

Malmo, 205 02, Sweden

Location

Capio St. Görans Sjukhus AB, kirurgkliniken

Stockholm, 112 45, Sweden

Location

Södersjukhuset

Stockholm, 117 61, Sweden

Location

karolinska Universitetssjukhuset Solna Stomimottagningen

Stockholm, 171 76, Sweden

Location

Stomimottagningen Centrllasarette i Västerås

Västerås, 721 89, Sweden

Location

Results Point of Contact

Title
Dr. Birte P.Jakobsen
Organization
Coloplast
dkbir@coloplast.com
+45 4911 1395

Study Officials

  • Birte P Jakobsen, MD

    Coloplast A/S

    PRINCIPAL INVESTIGATOR

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 1, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 8, 2014

Results First Posted

September 8, 2014

Record last verified: 2014-09

Locations

BE(1)DK(6)NL(1)NO(2)SE(7)