EnterostomyNCT05373888
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
An observational study of Enterostomy and Stoma Ileostomy, run by BBraun Medical SAS at 1 site in Spain.
Trial summary
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions for Use (IFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Flexima®/Softima® stoma bags
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 31 Mar 2023
- 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: Enterostomy patients, including colostomates, ileostomates or jejunostomates.
Who may be able to join
- Patients for whom the use of a Flexima®/Softima® appliance is indicated and has been decided within the regular planning of their treatment. Both, new users or users already using Flexima®/Softima® appliances are eligible for participation.
Who cannot join
- Patients under 18 years old
- Patients who are mentally or linguistically unable to understand the aim of the investigation; or unable to comply with the investigation procedures.
- Patients taking part in another clinical investigation which could have an impact on the current investigation.
- Patient vulnerable. Vulnerable patients are adults unable to express their consent, patients under legal protection, patients deprived of their liberty by a judicial or administrative decision, patients subject to psychiatric care against their will and pregnant, parturient or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundacion Jimenez Diaz
Madrid
Yolanda Ortega Perez, 0034 91 550 48 00, contacto@fjd.es
About this study
Official title: Prospective, Non-interventional, Post-Market Clinical Follow-up Investigation of the Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions for Use (IFU). The data obtained during routine clinical use will be documented in electronic Case Report Forms (eCRF).
The investigation will consist of an enrolment visit (Visit 1, or V1) and a final visit (Visit 2, or V2). The duration between the two visits is 14 (±3) days.
Read the detailed description
Details of the procedures performed at each visit follow.
#A ENROLMENT VISIT (Visit 1, onsite)
The following procedures will be performed:
- Informed consent
- Eligibility assessment
- Record demographics
- Record medical and surgical history (including stoma details)
- Record details of the appliance currently used, which could be different than a Flexima®/Softima®. However, participation in the investigation requires a Flexima®/Softima® appliance be used.
- Peristomal skin assessment (DET scoring)
- Discuss investigation requirements with the participant, including the need of adequately completing the patient's diary
- Start recording adverse events and concomitant medications
- B 14 (±3 DAY) DEVICE WEARING TIME (telephone follow-up)
During the wearing time, the following procedures will be done:
- The clinical site personnel will follow-up with the participants by telephone as required
- Participants will complete the patient's diary, which includes a record of appliance changes and assessment of leakages
- Record adverse events and concomitant medications (via telephone follow-up)
- C FINAL VISIT (Visit 2, onsite)
During the final visit, the following procedures will be done:
- Peristomal skin assessment (DET scoring)
- Participant evaluation of device performance (see 8.2.7)
- The responsible site personnel will review the patient's diary together with the patient. Any missing data will be discussed with the patient and, if possible, completed. In case it can't be completed, clarification notes explaining the reason for the missing data are to be added to the patient's diary (e.g. details forgotten)
- Record adverse events and concomitant medications
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Being tested
- Flexima®/Softima® stoma bags
- Keywords
- enterostomy, colostomy, ileostomy, stoma, jejunostomy, stoma appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexima®/Softima® stoma bagsDevice
One piece stoma bags for enterostomates available as:
- Closed (flat and convex)
- Drainable with Roll'Up (flat and convex)
- High flow with tape outlet (flat)
| Study group | Role | What they receive |
|---|---|---|
| Main | Enterostomy patients, including colostomates, ileostomates or jejunostomates. Receives: Device: Flexima®/Softima® stoma bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one adverse device effect (ADE) as judged by the clinician.
The primary variable is the number of patients with at least one adverse device effect (ADE) as judged by the clinician.
The occurrence of any of the following events in the peristomal skin may be considered related to the use of the stoma appliance (ie, ADEs):
- Allergic contact dermatitis
- Mechanical dermatitis - trauma
- Irritant-chemical dermatitis
- Infectious conditions
- Any other appliance related complication (as judged by the clinician)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT05373888
- Sponsor's protocol ID
- OPM-O-H-2005
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Post-Market Clinical Follow-up Investigation of the Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
- ClinicalTrials.gov ID
- NCT05373888
- Acronym / sponsor ID
- OPM-O-H-2005
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Keywords
- enterostomy, colostomy, ileostomy, stoma, jejunostomy, stoma appliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 13 May 2022 (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 is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions for Use (IFU). The data obtained during routine clinical use will be documented in electronic Case Report Forms (eCRF).
The investigation will consist of an enrolment visit (Visit 1, or V1) and a final visit (Visit 2, or V2). The duration between the two visits is 14 (±3) days.
Detailed description
Details of the procedures performed at each visit follow.
#A ENROLMENT VISIT (Visit 1, onsite)
The following procedures will be performed:
- Informed consent
- Eligibility assessment
- Record demographics
- Record medical and surgical history (including stoma details)
- Record details of the appliance currently used, which could be different than a Flexima®/Softima®. However, participation in the investigation requires a Flexima®/Softima® appliance be used.
- Peristomal skin assessment (DET scoring)
- Discuss investigation requirements with the participant, including the need of adequately completing the patient's diary
- Start recording adverse events and concomitant medications
- B 14 (±3 DAY) DEVICE WEARING TIME (telephone follow-up)
During the wearing time, the following procedures will be done:
- The clinical site personnel will follow-up with the participants by telephone as required
- Participants will complete the patient's diary, which includes a record of appliance changes and assessment of leakages
- Record adverse events and concomitant medications (via telephone follow-up)
- C FINAL VISIT (Visit 2, onsite)
During the final visit, the following procedures will be done:
- Peristomal skin assessment (DET scoring)
- Participant evaluation of device performance (see 8.2.7)
- The responsible site personnel will review the patient's diary together with the patient. Any missing data will be discussed with the patient and, if possible, completed. In case it can't be completed, clarification notes explaining the reason for the missing data are to be added to the patient's diary (e.g. details forgotten)
- Record adverse events and concomitant medications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | – | Device: Flexima®/Softima® stoma bagsEnterostomy patients, including colostomates, ileostomates or jejunostomates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enterostomy patients, including colostomates, ileostomates or jejunostomates.
Key inclusion criteria (1 listed)
- Patients for whom the use of a Flexima®/Softima® appliance is indicated and has been decided within the regular planning of their treatment. Both, new users or users already using Flexima®/Softima® appliances are eligible for participation.
Key exclusion criteria (4 listed)
- Patients under 18 years old
- Patients who are mentally or linguistically unable to understand the aim of the investigation; or unable to comply with the investigation procedures.
- Patients taking part in another clinical investigation which could have an impact on the current investigation.
- Patient vulnerable. Vulnerable patients are adults unable to express their consent, patients under legal protection, patients deprived of their liberty by a judicial or administrative decision, patients subject to psychiatric care against their will and pregnant, parturient or breastfeeding women.
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®/Softima® stoma bagsOne piece stoma bags for enterostomates available as: * Closed (flat and convex) * Drainable with Roll'Up (flat and convex) * High flow with tape outlet (flat) | Device | Main |
Primary outcome
Number of patients with at least one adverse device effect (ADE) as judged by the clinician.
Time frame: 14 days
The primary variable is the number of patients with at least one adverse device effect (ADE) as judged by the clinician. The occurrence of any of the following events in the peristomal skin may be considered related to the use of the stoma appliance (ie, ADEs): * Allergic contact dermatitis * Mechanical dermatitis - trauma * Irritant-chemical dermatitis * Infectious conditions * Any other appliance related complication (as judged by the clinician)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterostomy and Stoma Ileostomy, run by BBraun Medical SAS at 1 site in Spain.
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 1 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 13 May 2022. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with at least one adverse device effect (ADE) as judged by the clinician. (time frame: 14 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 13 May 2022.