Safety & Performance of Flexima®/Softima® Stoma Appliances in Enterostomy

Status Recruiting

Clinical 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). 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05373888
Study type	Observational
Source	BBraun Medical SAS
Contact
Status	Recruiting
Phase
Start date	April 1, 2022
Completion date	March 31, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms