EnterostomyNCT03572673
Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
A study testing Flexima 3S and New 2-piece ostomy appliance in people with Enterostomy, run by BBraun Medical SAS at 2 sites in Malaysia.
Trial summary
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece 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 3S and New 2-piece ostomy appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesMalaysia
- Study dates
- 8 May 2018to Apr 2019
- 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 having a colostomy or an ileostomy for at least 1 month
- patient currently using a flat appliance
- patient wearing his appliance, on average, at least 5 days
- patient with a stoma's diameter less than 65 mm
- patient who agrees to participate in the evaluation and who have signed the inform consent
- patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
Who cannot join
- Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- Patient receiving or having received, within the last month, chemotherapy or corticotherapy
- Patient already participating in another clinical study or who have previously participated in this investigation
- Pregnant or breast-feeding woman
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Selayang
Batu Caves, 68100
Fitjerald Henry, Dr, +6012-3730057, geraldh260311@gmail.com
- Recruiting
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, 56000
Ismail Sagap, Pr, +6019-3211261, drisagap@yahoo.com
About this study
Official title: Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
- Conditions
- Enterostomy
- Being tested
- Flexima 3S, New 2-piece ostomy appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexima 3SDevice
Also called Class 1 appliance for patients having an enterostoma
Flexima 3S (2-piece appliance) with drainable pouch
New 2-piece ostomy applianceDevice
Also called Class 1 appliance for patients having an enterostoma
New 2-piece ostomy appliance with drainable pouch
| Study group | Role | What they receive |
|---|---|---|
| Flexima 3S | Active comparator | Flexima 3S is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) Receives: Device: Flexima 3S |
| New 2-piece ostomy appliance | Experimental | New 2-piece appliance is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) Receives: Device: New 2-piece ostomy appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period
For each base plate, the wear time will be evaluated during 21 (±3) days
Measured: On average every 5 days, up to 21 (±3) days for each period
Secondary outcomes (6)
Assessment of the condition of peristomal skin
Using a standardized measuring ostomy skin tool
Measured: After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)
Assessment of the main reason of base plate removal
After each base plate removal, the patient will describe on a 7-point scale the main reason of base plate removal ("habit", "hygiene", "leakage under the base plate", "unsticking of the base plate periphery", "unsticking of the base plate, not only on the periphery", "ask for the study but the base plate could stay longer in place", "other, to specify". No value is considered as the better outcome, it's only descriptive value.
Measured: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
Assessment of acceptability
At the end of each study period (21 (±3) days), the patient will assess on a 4-point scale each parameter of acceptability ("very good", "good", "bad", "very bad". The "very good" value is considered as the better outcome.
Measured: At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days)
Assessment of use of accessories
After each base plate removal, the patient will describe on a 8-point scale the use of accessories ("none", "protective spray", "powder", "paste", "ring", "adhesive remover", "belt", "other, to specify". No value is considered as the better outcome, it's only descriptive value.
Measured: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
Preference between Flexima® 3S and the new 2-piece ostomy appliance
At the end of the study, the patient will notify the preference between Flexima® 3S and the new 2-piece appliance
Measured: At the end of the study, at 42 (±6) days
Safety: Adverse(s) Event(s)
Description of all adverse event related or not to the devices studied
Measured: From date of randomization until the date of first adverse event, assessed up to 42 (±6) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start8 May 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572673
- Sponsor's protocol ID
- OPM-G-H-1705
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
- ClinicalTrials.gov ID
- NCT03572673
- Acronym / sponsor ID
- OPM-G-H-1705
- Conditions
- Enterostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 28 Jun 2018 (actual)
- 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.
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexima 3S | Active comparator | Device: Flexima 3SFlexima 3S is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) |
| New 2-piece ostomy appliance | Experimental | Device: New 2-piece ostomy applianceNew 2-piece appliance is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient having a colostomy or an ileostomy for at least 1 month
- patient currently using a flat appliance
- patient wearing his appliance, on average, at least 5 days
- patient with a stoma's diameter less than 65 mm
- patient who agrees to participate in the evaluation and who have signed the inform consent
Key exclusion criteria (4 listed)
- Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- Patient receiving or having received, within the last month, chemotherapy or corticotherapy
- Patient already participating in another clinical study or who have previously participated in this investigation
- Pregnant or breast-feeding woman
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 3SAlso: Class 1 appliance for patients having an enterostomaFlexima 3S (2-piece appliance) with drainable pouch | Device | Flexima 3S |
| New 2-piece ostomy applianceAlso: Class 1 appliance for patients having an enterostomaNew 2-piece ostomy appliance with drainable pouch | Device | New 2-piece ostomy appliance |
Primary outcome
Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period
Time frame: On average every 5 days, up to 21 (±3) days for each period
For each base plate, the wear time will be evaluated during 21 (±3) days
6 secondary outcomes
Assessment of the condition of peristomal skin
Time frame: After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)
Assessment of the main reason of base plate removal
Time frame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
Assessment of acceptability
Time frame: At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days)
Assessment of use of accessories
Time frame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
Preference between Flexima® 3S and the new 2-piece ostomy appliance
Time frame: At the end of the study, at 42 (±6) days
Safety: Adverse(s) Event(s)
Time frame: From date of randomization until the date of first adverse event, assessed up to 42 (±6) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexima 3S and New 2-piece ostomy appliance in people with Enterostomy, run by BBraun Medical SAS at 2 sites in Malaysia.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aude Michaud (+33632542788, aude.michaud@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period (time frame: On average every 5 days, up to 21 (±3) days for each period). 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 28 Jun 2018.