CompletedNCT01957462Updated Sep 26, 2016Results posted

Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

An interventional study of Coloplast Test V and Coloplast Test X in Ileostomy - Stoma and Colostomy - Stoma, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 31
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.

Conditions studied

Ileostomy - Stoma
Colostomy - Stoma

In context

Lead sponsor

Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have given written informed consent and signed letter of authority.
Are at least 18 years of age and have full legal capacity.
Have had their ostomy (ileo- or colostomy) for at least 3 months.
Have used a 1-piece convex ostomy product during the last month.
Are willing and able to comply with investigation procedures.
Have a ostomy with a diameter of 33 mm or less.

Exclusion criteria

Exclusion Criteria:

Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
Are pregnant or breastfeeding.
Have a loop ostomy (also called double-barrel or ostomy with two outlets).
Known hypersensitivity toward any of the test products.
Use irrigation during the investigation (flush the stoma with water).
Participating in other interventional clinical investigations or have previously participated in this investigation.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Device: Coloplast Test V · Device: Coloplast Test X
Experimental
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Device: Coloplast Test V · Device: Coloplast Test X

Interventions

DeviceColoplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Also known as: Coloplast 1-piece convex Test product V
DeviceColoplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
Also known as: Coloplast 1-piece convex Test product X

What researchers measure

Primary outcomes

Degree of Leakage
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change
Time frame: 14 days

Results

Posted Aug 11, 2014

Participant flow

Test Period 1

Participant flow — Test Period 1
Milestone	FirstColplast Test V, Then Coloplast Test X	First Coloplast Test X, Then Coloplast Test V
Started	16	15
Completed	14	15
Not completed	2	0
Withdrew: Withdrawal by subject	1	0
Withdrew: Adverse event	1	0

Test Period 2

Participant flow — Test Period 2
Milestone	FirstColplast Test V, Then Coloplast Test X	First Coloplast Test X, Then Coloplast Test V
Started	14	15
Completed	14	15
Not completed	0	0

Outcome measures

PrimaryDegree of Leakage

The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change

Time frame:: 14 days
Reported as:: Mean · units on a scale

Degree of Leakage
units on a scale	Test V	Test X
Degree of Leakage	3.5 ± 5.0	3.1 ± 5.1

Adverse events

Collected over 28+/- 3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test V	—	1/31 (3.2%)	13/31 (41.9%)
Test X	—	1/29 (3.4%)	13/29 (44.8%)

Most frequent serious events

Most frequent serious events
Event	Test V	Test X
constipationGastrointestinal disorders	0/31	1/29
Absess in the bowl ( by a fistel channel 2 mm from stoma)Gastrointestinal disorders	1/31	0/29

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Test V	Test X
peristomal skin irritationSkin and subcutaneous tissue disorders	7/31	7/29
Peristomal ItchingSkin and subcutaneous tissue disorders	5/31	1/29
Petekkie/pressure mark (peristomal)Skin and subcutaneous tissue disorders	1/31	2/29
Peristomal skin PainSkin and subcutaneous tissue disorders	0/31	1/29
ObstipationGastrointestinal disorders	0/31	1/29
dehydration due to obstpationMetabolism and nutrition disorders	0/31	1/29
fatigueGeneral disorders	0/31	1/29
sore throatInfections and infestations	0/31	1/29
broken skinSkin and subcutaneous tissue disorders	1/31	0/29
Pain and sorness by stoma and´in bowlGastrointestinal disorders	1/31	0/29

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Subjects
Mean	61.4 ± 12.7

Sex: Female, Male
Sex: Female, Male(Participants)	All Subjects
Female	24
Male	7

Study locations

1 site

Coloplast A/S
Humlebæk, 3050, Denmark

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01957462
Lead sponsor: Coloplast A/S
Responsible party: Sponsor
First posted: Oct 8, 2013
Start date: Apr 2013
Primary completion: May 2013
Completion: May 2013
Results posted: Aug 11, 2014
Last update: Sep 26, 2016

Study contacts

Birte P Jakobsen, MD

principal investigator · Coloplast A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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