Stoma IleostomyNCT01800916

Safety and Performance of New 1-piece Ostomy Product

A study testing Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B and Coloplast Adhesive baseplate C in people with Stoma 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

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Stoma Ileostomy
What is being tested?: Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B and Coloplast Adhesive baseplate C
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteDenmark
Study dates: Feb 2013to May 2013
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

Have given written informed consent and signed letter of authority form.
Be at least 18 years of age and have full legal capacity.
Be able to handle the bags themselves.
Have an ileostomy with a diameter between 15 and 40 mm.
Have had their ostomy for at least three months.
Currently use a 1-piece flat ostomy appliance with open bag.

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Use minimum 1 ostomy appliance every second day.
Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
Must be able to use a custom cut ostomy appliance.
Accept to test three 1-piece ostomy appliances in the investigation.
Negative result of a pregnancy test for women of childbearing age (only DK).

Who cannot join

Use irrigation during the study (flush the stoma with water).
Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
Are pregnant or breastfeeding.
Participating in other interventional clinical investigations or have previously participated in this investigation.
Currently using ostomy belt.

Show all 9Show fewer

Currently using extended wear product.
Known hypersensitivity towards any of the test products
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

Holtedam 3
Humlebæk, 3050

Other trials in Denmark

About this study

Official title: Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

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

Read the detailed description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Conditions: Stoma Ileostomy
Being tested: Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C, SenSura 1-Piece
Keywords: ileostomy, Subjects

What participants receive

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

Coloplast Adhesive baseplate ADevice
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Coloplast Adhesive baseplate BDevice
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
Coloplast Adhesive baseplate CDevice
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
SenSura 1-PieceDevice
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Study groups in NCT01800916
Study group	Role	What they receive
Treatment sequence 1	Experimental	The subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB Receives: Device: Coloplast Adhesive baseplate A; Device: Coloplast Adhesive baseplate B; Device: SenSura 1-Piece
Treatment sequence 2	Experimental	The subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB Receives: Device: Coloplast Adhesive baseplate B; Device: Coloplast Adhesive baseplate C; Device: SenSura 1-Piece
Treatment sequence 3	Experimental	The subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC Receives: Device: Coloplast Adhesive baseplate A; Device: Coloplast Adhesive baseplate C; Device: SenSura 1-Piece

What is being measured

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

Degree of Leakage
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.
The subjects had to tick off one of the following choices:
1. No leakage
2. Starting to leak
3. Leakage
4. Sudden Leakage
Measured: one week

Timeline

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

Feb 2013May 2013

First posted28 Feb 2013 (estimated)
Study startFeb 2013
Primary completionMay 2013
Study completionMay 2013

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 Stoma 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
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01800916
Sponsor's protocol ID: CP236
Status last verified: Mar 2017
First submitted: 22 Feb 2013
Last updated: 14 Apr 2017
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

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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
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
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All Stoma Ileostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy
ClinicalTrials.gov ID: NCT01800916
Acronym / sponsor ID: CP236
Conditions: Stoma Ileostomy
Keywords: ileostomy, Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 28 Feb 2013 (estimated)
Results: Posted 30 May 2014

Clinical summary

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

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

Detailed description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment sequence 1	Experimental	Device: Coloplast Adhesive baseplate A, Device: Coloplast Adhesive baseplate B, Device: SenSura 1-PieceThe subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB
Treatment sequence 2	Experimental	Device: Coloplast Adhesive baseplate B, Device: Coloplast Adhesive baseplate C, Device: SenSura 1-PieceThe subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB
Treatment sequence 3	Experimental	Device: Coloplast Adhesive baseplate A, Device: Coloplast Adhesive baseplate C, Device: SenSura 1-PieceThe subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC

Who may qualify

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

Key inclusion criteria (11 listed)

Have given written informed consent and signed letter of authority form.
Be at least 18 years of age and have full legal capacity.
Be able to handle the bags themselves.
Have an ileostomy with a diameter between 15 and 40 mm.
Have had their ostomy for at least three months.

Key exclusion criteria (9 listed)

Use irrigation during the study (flush the stoma with water).
Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
Are pregnant or breastfeeding.
Participating in other interventional clinical investigations or have previously participated in this investigation.

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
Coloplast Adhesive baseplate AColoplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.	Device	Treatment sequence 1, Treatment sequence 3
Coloplast Adhesive baseplate BColoplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance	Device	Treatment sequence 1, Treatment sequence 2
Coloplast Adhesive baseplate CColoplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance	Device	Treatment sequence 2, Treatment sequence 3
SenSura 1-PieceSenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .	Device	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3

Primary outcome

Degree of Leakage
Time frame: one week
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage

Results and safety

Results posted to the registry on 30 May 2014, 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/Test B/SenSura	7	7
Test A/Test C/SenSura	7	7
Test B/SenSura/Test A	7	7
Test B/SenSura/Test C	7	6
Test C/Test B/SenSura	8	7
Test C/SenSura/Test A	7	7
SenSura/Test A/Test B	7	7
SenSura/Test A/Test C	7	7
SenSura/Test C/Test B	7	7

Primary outcome: Degree of Leakage

Time frame: one week. Number. Unit: percentage of baseplates with no leakage

Measure	Test A n = 42	Test B n = 41	Test C n = 42	SenSura n = 62
Value	50	44	41	60

Population analysed: The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.

Adverse events

Time frame: The adverse events were collected during the investigation - up to three weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test A	1 of 42 (2.4%)	18 of 42 (42.9%)	Not reported
Test B	1 of 42 (2.4%)	12 of 42 (28.6%)	Not reported
Test C	0 of 42 (0%)	11 of 42 (26.2%)	Not reported
SenSura	0 of 62 (0%)	13 of 62 (21%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stoma Ileostomy

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
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma

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 Jakobsen, Dr. 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 Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B and Coloplast Adhesive baseplate C in people with Stoma 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 11 inclusion and 9 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 14 Apr 2017. 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 30 May 2014). 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 NCT01800916.

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 14 Apr 2017.