ColostomyNCT02602236
Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
A study testing AOS-C2000-B in people with Colostomy, run by BBraun Medical SAS at 1 site in France.
Trial summary
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- AOS-C2000-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Oct 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 with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- Patient having a colostomy for at least 1 month
- Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
- Patient having a stoma protusion smaller than or equal to 1.5 cm
- Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
Show all 9Show fewer
- 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 the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
- Patient covered by social security
Who cannot join
- Patient experiencing repeated leakages with the usual pouching system
- 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, radiotherapy 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
1 site in 1 country.
About this study
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Conditions
- Colostomy
- Being tested
- AOS-C2000-B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOS-C2000-BDevice
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
| Study group | Role | What they receive |
|---|---|---|
| AOS-C2000-B | Experimental | A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day) Receives: Device: AOS-C2000-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of efficacy in term of type of bag deployment and leakage prevention
After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
Measured: At least 1 time per day during 14±3 days
Secondary outcomes (28)
Peristomal skin evaluation with DET score scale
Measured: baseline and 5±3 days and 14±3 days
Investigational product bag deployment reason
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: At each bag change during 14±3 days
Ease of bag deployment
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Ease of special bag handling
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational product bag ease of use of gas release button
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Ease of control of gas release button
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
General impression about the investigational device before use
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device wearing comfort
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device flexibility
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device discretion
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Ease of base plate handling
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device adhesivity during wear time
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device filter performance with deployed bag
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Investigational device filter performance with undeployed bag
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Efficacy of Investigational device gas release button
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Noise during Investigational device wear time
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
Measured: 14±3 days
Overall security feeling questionnaire with the Investigational device
Measured: 14±3 days
Overall satisfaction questionnaire with the Investigational device
Measured: 14±3 days
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Measured: 14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device
Measured: 14±3 days
General impression about body image during use of the investigational product
(4-points very satisfying to not at all satisfying)
Measured: 14±3 days
Assessment questionnaire of willingness to use and the frequency of use in the future
Measured: 14±3 days
Assessment of the investigational device wear time
Measured: 14±3 days
Assessment questionnaire preference between the investigational device and usual appliance
Measured: 14±3 days
Assessment of use of accessories
Choice between some accessories
Measured: At each bag change during 14±3 days
Assessment of the quality of life with Stoma-QoL questionnaire
Measured: At baseline, at 5±3 days and 14±3 days
Number of participants with Adverse Event as a measure of safety and tolerability
Measured: At baseline, at 5±3 days and 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 posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Investigational product needs improvements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahaut LECONTE, MD, Principal investigator, University Hospital of Paris - Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602236
- Sponsor's protocol ID
- OPM-G-H-1401
- Other IDs
- 2015-A00611-48
- Status last verified
- Feb 2017
- First submitted
- 4 Nov 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
- ClinicalTrials.gov ID
- NCT02602236
- Acronym / sponsor ID
- OPM-G-H-1401
- Conditions
- Colostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational product needs improvements
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Nov 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.
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AOS-C2000-B | Experimental | Device: AOS-C2000-BA new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is at least 18 years old
- Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- Patient having a colostomy for at least 1 month
- Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
- Patient having a stoma protusion smaller than or equal to 1.5 cm
Key exclusion criteria (5 listed)
- Patient experiencing repeated leakages with the usual pouching system
- 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, radiotherapy 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 |
|---|---|---|
| AOS-C2000-B1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day | Device | AOS-C2000-B |
Primary outcome
Description of efficacy in term of type of bag deployment and leakage prevention
Time frame: At least 1 time per day during 14±3 days
After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
28 secondary outcomes
Peristomal skin evaluation with DET score scale
Time frame: baseline and 5±3 days and 14±3 days
Investigational product bag deployment reason
Time frame: At each bag change during 14±3 days
Ease of bag deployment
Time frame: 14±3 days
Ease of special bag handling
Time frame: 14±3 days
Investigational product bag ease of use of gas release button
Time frame: 14±3 days
Ease of control of gas release button
Time frame: 14±3 days
General impression about the investigational device before use
Time frame: 14±3 days
Investigational device wearing comfort
Time frame: 14±3 days
Investigational device flexibility
Time frame: 14±3 days
Investigational device discretion
Time frame: 14±3 days
Ease of base plate handling
Time frame: 14±3 days
Investigational device adhesivity during wear time
Time frame: 14±3 days
Investigational device filter performance with deployed bag
Time frame: 14±3 days
Investigational device filter performance with undeployed bag
Time frame: 14±3 days
Efficacy of Investigational device gas release button
Time frame: 14±3 days
Noise during Investigational device wear time
Time frame: 14±3 days
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
Time frame: 14±3 days
Overall security feeling questionnaire with the Investigational device
Time frame: 14±3 days
Overall satisfaction questionnaire with the Investigational device
Time frame: 14±3 days
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Time frame: 14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device
Time frame: 14±3 days
General impression about body image during use of the investigational product
Time frame: 14±3 days
Assessment questionnaire of willingness to use and the frequency of use in the future
Time frame: 14±3 days
Assessment of the investigational device wear time
Time frame: 14±3 days
Assessment questionnaire preference between the investigational device and usual appliance
Time frame: 14±3 days
Assessment of use of accessories
Time frame: At each bag change during 14±3 days
Assessment of the quality of life with Stoma-QoL questionnaire
Time frame: At baseline, at 5±3 days and 14±3 days
Number of participants with Adverse Event as a measure of safety and tolerability
Time frame: At baseline, at 5±3 days and 14±3 days
Results and safety
The study was stopped early (reason given: Investigational product needs improvements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
Mahaut LECONTE, MD principal investigator
University Hospital of Paris - Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOS-C2000-B in people with Colostomy, 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 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: stopped early, as of the sponsor's last update on 6 Feb 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 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 was stopped early (reason given: Investigational product needs improvements). Results are not available in the source record.
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?
Description of efficacy in term of type of bag deployment and leakage prevention (time frame: At least 1 time per day during 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 6 Feb 2017.