Stoma ColostomyPhase 4NCT01513330

Performance Study of Newly Developed Ostomy Products

A Phase 4 study testing SenSura Mio in people with Stoma Colostomy, run by Coloplast A/S at 1 site in Germany.

Completed

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

Trial summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stoma Colostomy
What is being tested?: SenSura Mio
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteGermany
Study dates: Nov 2011to Aug 2012
Phase: Phase 4
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.
Be at least 18 years of age and have full legal capacity.
Have experienced leakage under the base plate at least once a week over the last two weeks.
Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
Have a colostomy with a diameter between 20 and 45 mm.
Have had their ostomy for at least three months.

Show all 9Show fewer

Currently use a 1-piece flat product with closed bag.
Use minimum 1 product per day.
Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

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 month 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Publicare
Cologne, Køln

Other trials in Germany

About this study

Official title: An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

Conditions: Stoma Colostomy
Being tested: SenSura Mio, Standard Care

What participants receive

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

SenSura MioDevice
Ostomy product - 1 piece closed bag
Standard CareDevice
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

Study groups in NCT01513330
Study group	Role	What they receive
First Standard Care, then SenSura Mio	Experimental	Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio Receives: Device: SenSura Mio; Device: Standard Care
First SenSura Mio, then Standard Care	Experimental	Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) Receives: Device: SenSura Mio; Device: Standard Care

What is being measured

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

Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
Measured: 14 days

Timeline

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

Nov 2011Aug 2012

First posted20 Jan 2012 (estimated)
Study startNov 2011
Primary completionJun 2012
Study completionAug 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 Stoma ColostomyStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01513330
Sponsor's protocol ID: CP219
Status last verified: Nov 2013
First submitted: 10 Jan 2012
Last updated: 9 Jan 2014
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

RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
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
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Ileostomy - Stoma, Colostomy - Stoma

All Stoma Colostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.
ClinicalTrials.gov ID: NCT01513330
Acronym / sponsor ID: CP219
Conditions: Stoma Colostomy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jun 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 20 Jan 2012 (estimated)
Results: Posted 9 Jan 2014

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
First Standard Care, then SenSura Mio	Experimental	Device: SenSura Mio, Device: Standard CareSubjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio
First SenSura Mio, then Standard Care	Experimental	Device: SenSura Mio, Device: Standard CareSubjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)

Who may qualify

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

Key inclusion criteria (9 listed)

Have given written informed consent.
Be at least 18 years of age and have full legal capacity.
Have experienced leakage under the base plate at least once a week over the last two weeks.
Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
Have a colostomy with a diameter between 20 and 45 mm.

Key exclusion criteria (5 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 month 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
SenSura MioOstomy product - 1 piece closed bag	Device	First SenSura Mio, then Standard Care, First Standard Care, then SenSura Mio
Standard CareOstomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.	Device	First SenSura Mio, then Standard Care, First Standard Care, then SenSura Mio

Primary outcome

Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Time frame: 14 days
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.

Results and safety

Results posted to the registry on 9 Jan 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
First SenSura Mio, Then Standard Care	64	60
First Standard Care, Then SenSura Mio	58	56

Primary outcome: Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)

Time frame: 14 days. Mean (Standard Deviation). Unit: points on a scale

Measure	SenSura Mio n = 120	Standard Care n = 118
Value	3.8 (5.0)	3.4 (4.4)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SenSura Mio	0 of 120 (0%)	10 of 120 (8.3%)	Not reported
Standard Care	0 of 118 (0%)	10 of 118 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stoma Colostomy

RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
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
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Ileostomy - Stoma, Colostomy - 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.

Wenche Sundberg, stoma nurse principal investigator

Diakonhjemmet Sykhus, Oslo

Merete Bjørke, Stoma Nurse principal investigator

St. Olavs Hopsital

Vigids Dagsland, Stoma Nurse principal investigator

Haugesund Sykhus

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SenSura Mio in people with Stoma Colostomy, run by Coloplast A/S at 1 site in Germany.

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 9 inclusion and 5 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 9 Jan 2014. 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 Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 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. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) (time frame: 14 days). 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 NCT01513330.

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 9 Jan 2014.