OstomyKISSSNCT03133585
Study on the Stoma Appliance Flexima®/Softima® 3S
An observational study of Ostomy, run by BBraun Medical SAS at 2 sites in France.
Trial summary
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- What is being tested?
- 2 piece appliance for stomy
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Aug 2017to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Patient with a Enterostomy or an urostomy
Who may be able to join
- Patient is at least 18 years old
- Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month
- Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements
- Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment
Who cannot join
- Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem
- Patient taking part in another clinical evaluation
- Patient having more than one stomy
- Patient vulnerable and under legal protection
- Patient having had an known allergy to one of the components of the appliance
- Patient previously using Flexima®/Softima® 3S
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU Lapeyronie
Montpellier, 34000
Marie-Noelle Mrs Bernassau
- Not yet recruiting
Hopital Tenon
Paris, Île-de-France Region, 75020
Daniel Mrs Chaumier
About this study
Official title: Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Read the detailed description
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
- Conditions
- Ostomy
- Being tested
- 2 piece appliance for stomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 piece appliance for stomyDevice
Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1))
Measured: the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start23 Aug 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VERTICAL, EVAMED
- Responsible party
- Sponsor
- Investigators
- Danièle Chaumier, Principal investigator, Hopital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133585
- Sponsor's protocol ID
- OPM-O-H-1502
- Acronym
- KISSS
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2017
- Last updated
- 17 Apr 2019
- 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S
- ClinicalTrials.gov ID
- NCT03133585
- Acronym / sponsor ID
- KISSS / OPM-O-H-1502
- Conditions
- Ostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Collaborators
- VERTICAL, EVAMED
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 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.
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Detailed description
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a Enterostomy or an urostomy
Key inclusion criteria (4 listed)
- Patient is at least 18 years old
- Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month
- Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements
- Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment
Key exclusion criteria (6 listed)
- Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem
- Patient taking part in another clinical evaluation
- Patient having more than one stomy
- Patient vulnerable and under legal protection
- Patient having had an known allergy to one of the components of the appliance
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 |
|---|---|---|
| 2 piece appliance for stomyUse of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change | Device | – |
Primary outcome
evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up
Time frame: the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
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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.
Danièle Chaumier principal investigator
Hopital Tenon, Paris, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy, run by BBraun Medical SAS at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghislaine Martin (141107563 ext. +33, ghislaine.martin@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up (time frame: the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.). 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 17 Apr 2019.