Colostomy StomaNCT03108105
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
A study testing AOS-C2001-B in people with Colostomy Stoma, 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 Stoma
- What is being tested?
- AOS-C2001-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 7 Nov 2017
- 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 a flat ostomy appliance
- 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 evaluation 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
Official title: Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Conditions
- Colostomy Stoma
- Being tested
- AOS-C2001-B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOS-C2001-BDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| AOS-C2001-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-C2001-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of efficacy in terms of stool collection and leakage prevention
After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal
Measured: At least 1 time per day during 14±3 days
Description of efficacy in terms of stool collection and leakage prevention
After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage
Measured: At least 1 time per day during 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 Apr 2017
- Study start1 Jun 2017
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy StomaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108105
- Sponsor's protocol ID
- OPM-G-H-1604
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2017
- Last updated
- 24 Apr 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 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
- ClinicalTrials.gov ID
- NCT03108105
- Acronym / sponsor ID
- OPM-G-H-1604
- Conditions
- Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 11 Apr 2017 (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.
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-C2001-B | Experimental | Device: AOS-C2001-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 a flat ostomy appliance
- 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-C2001-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) | Device | AOS-C2001-B |
Primary outcome
Description of efficacy in terms of stool collection 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 4-point scale the type of capsule cap cover removal
Description of efficacy in terms of stool collection 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 4-point scale the level of leakage
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 24 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Colostomy Stoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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-C2001-B in people with Colostomy Stoma, 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: finished, as of the sponsor's last update on 24 Apr 2018. 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?
Description of efficacy in terms of stool collection and leakage prevention (time frame: At least 1 time per day during 14±3 days). The study lists 2 primary outcomes in all. 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 24 Apr 2018.