IleostomyNCT01514136

An Investigation of Ostomy Devices

A study testing Ostomy appliance: convex 1-piece drainable in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The secondary objective is to investigate several performance and safety parameters of the various devices. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ileostomy
What is being tested?: Ostomy appliance: convex 1-piece drainable
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteDenmark
Study dates: Sep 2011to Jan 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be at least 18 years old
Have signed the declaration of informed consent
Have an ileostomy in a concave area
Have had an ileostomy for at least three months
Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month
Be users of 1-piece or 2-piece open ostomy devices
Have an ileostomy with a diameter of less than 33 mm

Who cannot join

Are pregnant or breast-feeding
Have a double-loop ileostomy
Have known hypersensitivity or allergy to the devices' component ingredients
Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
Are receiving/have received local peristomal or systemic steroid treatment within the last month
Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Coloplast A/S
Humlebæk, Denmark, 3050

Other trials in Denmark

About this study

Official title: CP216: An Exploratory Investigation of Convex Ostomy Devices

Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Conditions: Ileostomy
Being tested: Ostomy appliance: convex 1-piece drainable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ostomy appliance: convex 1-piece drainableDevice
8 variations of an ostomy devices are tested

Study groups in NCT01514136
Study group	Role	What they receive
One arm	Experimental	The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A, B, C, D. Receives: Device: Ostomy appliance: convex 1-piece drainable

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of Leakage
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.
The scale was developed by Coloplast A/S
Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jan 2012

First posted20 Jan 2012 (estimated)
Study startSep 2011
Primary completionDec 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for IleostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01514136
Sponsor's protocol ID: CP216
Status last verified: Feb 2015
First submitted: 10 Jan 2012
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula

All Ileostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CP216: An Exploratory Investigation of Convex Ostomy Devices
ClinicalTrials.gov ID: NCT01514136
Acronym / sponsor ID: CP216
Conditions: Ileostomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Dec 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 20 Jan 2012 (estimated)
Results: Posted 29 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
One arm	Experimental	Device: Ostomy appliance: convex 1-piece drainableThe arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A, B, C, D.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Be at least 18 years old
Have signed the declaration of informed consent
Have an ileostomy in a concave area
Have had an ileostomy for at least three months
Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month

Key exclusion criteria (6 listed)

Are pregnant or breast-feeding
Have a double-loop ileostomy
Have known hypersensitivity or allergy to the devices' component ingredients
Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
Are receiving/have received local peristomal or systemic steroid treatment within the last month

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ostomy appliance: convex 1-piece drainable8 variations of an ostomy devices are tested	Device	One arm

Primary outcome

Degree of Leakage
Time frame: One week
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S

Results and safety

Results posted to the registry on 29 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test A	25	22
Test B	0	0
Test C	0	0
Test D	0	0
Test A*	0	0
Test B*	0	0
Test C*	0	0
Test D*	0	0

Primary outcome: Degree of Leakage

Time frame: One week. Mean (Standard Deviation). Unit: units on a scale

Measure	Test A - Convex Product Users n = 18	Test B - Convex Product Users n = 19	Test C - Convex Product Users n = 19	Test D - Convex Product Users n = 19	Test A* - Convex Product Users n = 19	Test B* - Convex Product Users n = 20	Test C* - Convex Product Users n = 18	Test D* - Convex Product Users n = 16	Test A - Flat Product Users n = 7	Test B - Flat Product Users n = 5	Test C - Flat Product Users n = 5	Test D - Flat Product Users n = 7	Test A* - Flat Product Users n = 9	Test B* - Flat Product Users n = 8	Test C* - Flat Product Users n = 8	Test D* - Flat Product Users n = 7
Value	4.2 (0.6)	4.3 (0.8)	4.4 (0.7)	4.3 (0.8)	3.4 (0.7)	2.9 (0.6)	3.3 (0.7)	4.1 (0.8)	2.1 (1.4)	0.1 (0.04)	0.1 (0.1)	2.4 (1.3)	3.1 (1.5)	3.6 (1.8)	3.8 (1.8)	3.0 (1.6)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test A	0 of 26 (0%)	8 of 26 (30.8%)	Not reported
Test B	0 of 24 (0%)	6 of 24 (25%)	Not reported
Test C	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Test D	0 of 26 (0%)	3 of 26 (11.5%)	Not reported
Test A*	1 of 28 (3.6%)	3 of 28 (10.7%)	Not reported
Test B*	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
Test C*	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
Test D*	0 of 23 (0%)	3 of 23 (13%)	Not reported

Limitations and caveats (from the sponsor): This was an exploratory investigation where the participating subjects had to test 8 different test products. A small number of subjects were analysed from two different populations (convex product/flat product users).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ileostomy

RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Birte P Jakobsen, MD principal investigator

Coloplast A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ostomy appliance: convex 1-piece drainable in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of Leakage (time frame: One week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01514136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.