EnterostomyNCT02507726
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
A study testing Flexima Active soft convexe in people with Enterostomy, run by BBraun Medical SAS at 1 site in France.
Trial summary
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterostomy
- What is being tested?
- Flexima Active soft convexe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patient is at least 18 years old,
- patient having a colostomy or an ileostomy for at least 1 month,
- patient having a stoma's diameter inferior to 45 mm,
- patient having a flat or flushed or slightly retracted stoma,
- patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
- patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
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- patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
- patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- patient agreeing to test investigational product during 14(±3) days.
- patient covered by social security
Who cannot join
- patient experiencing repeated leakages with his current appliance,
- patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
- patient having a deeply retracted stoma,
- patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
- patient already participating in another clinical study or who have previously participated in this investigation,
- pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Read the detailed description
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin protector
Secondary Outcome Measure:
- Assessment of the condition of peristomal skin
- Assessment of other performance criteria
- Assessment of AEs for each patient
- Conditions
- Enterostomy
- Being tested
- Flexima Active soft convexe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexima Active soft convexeDevice
The Investigational Device will be used during 14 +- 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Flexima Active Soft convexe | Experimental | Flexima Active soft convexe (1 to 3 appliances per day) Receives: Device: Flexima Active soft convexe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
Measured: 14 +- 3 days
Secondary outcomes (15)
Peristomal skin evaluation with DET score scale
Measured: baseline and 14 +- 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: baseline and 14 +- 3 days
Investigational product wear time
The patient will complete his patient diary after each Investigational Product removal
Measured: 14 +- 3 days
Investigational product adhesivity as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Investigational product flexibility as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Investigational product conformability as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Ease of Investigational Product handling as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Investigational Product wearing comfort as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Investigational Product leakage prevention as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Feeling of Investigational Product security as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Investigational Product overall satisfaction as measured by a Likert scale score (1-4)
Measured: 14 +- 3 days
Use of Investigational Product in the future as measured by a Likert scale score (1-2)
Measured: 14 +- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterostomyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick RAT, MD, Principal investigator, University Hospital of Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507726
- Sponsor's protocol ID
- OPM-G-H-1501
- Status last verified
- Sep 2016
- First submitted
- 3 Jul 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
- ClinicalTrials.gov ID
- NCT02507726
- Acronym / sponsor ID
- OPM-G-H-1501
- Conditions
- Enterostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Detailed description
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin protector
Secondary Outcome Measure:
- Assessment of the condition of peristomal skin
- Assessment of other performance criteria
- Assessment of AEs for each patient
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexima Active Soft convexe | Experimental | Device: Flexima Active soft convexeFlexima Active soft convexe (1 to 3 appliances per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patient is at least 18 years old,
- patient having a colostomy or an ileostomy for at least 1 month,
- patient having a stoma's diameter inferior to 45 mm,
- patient having a flat or flushed or slightly retracted stoma,
- patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
Key exclusion criteria (6 listed)
- patient experiencing repeated leakages with his current appliance,
- patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
- patient having a deeply retracted stoma,
- patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
- patient already participating in another clinical study or who 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 |
|---|---|---|
| Flexima Active soft convexeThe Investigational Device will be used during 14 +- 3 days. | Device | Flexima Active Soft convexe |
Primary outcome
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
Time frame: 14 +- 3 days
15 secondary outcomes
Peristomal skin evaluation with DET score scale
Time frame: baseline and 14 +- 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: baseline and 14 +- 3 days
Investigational product wear time
Time frame: 14 +- 3 days
Investigational product adhesivity as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational product flexibility as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational product conformability as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Ease of Investigational Product handling as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product wearing comfort as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product leakage prevention as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Feeling of Investigational Product security as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product overall satisfaction as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Use of Investigational Product in the future as measured by a Likert scale score (1-2)
Time frame: 14 +- 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Patrick RAT, MD principal investigator
University Hospital of Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexima Active soft convexe in people with Enterostomy, run by BBraun Medical SAS at 1 site in France.
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 10 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 23 Sep 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector (time frame: 14 +- 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2016.