Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
Not Applicable
Completed
- Conditions
- Enterostomy
- Interventions
- Device: Flexima Active soft convexe
- Registration Number
- NCT02507726
- Lead Sponsor
- BBraun Medical SAS
- Brief Summary
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
- Detailed Description
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin protector
Secondary Outcome Measure:
* Assessment of the condition of peristomal skin
* Assessment of other performance criteria
* Assessment of AEs for each patient
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- patient is at least 18 years old,
- patient having a colostomy or an ileostomy for at least 1 month,
- patient having a stoma's diameter inferior to 45 mm,
- patient having a flat or flushed or slightly retracted stoma,
- patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
- patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
- patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
- 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 investigational product during 14(±3) days.
- patient covered by social security
Exclusion Criteria
- patient experiencing repeated leakages with his current appliance,
- patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
- patient having a deeply retracted stoma,
- patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
- patient already participating in another clinical study or who have previously participated in this investigation,
- pregnant or breast-feeding woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Flexima Active Soft convexe Flexima Active soft convexe Flexima Active soft convexe (1 to 3 appliances per day)
- Primary Outcome Measures
Name Time Method Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector 14 +- 3 days
- Secondary Outcome Measures
Name Time Method Peristomal skin evaluation with DET score scale baseline and 14 +- 3 days Investigational product conformability as measured by a Likert scale score (1-4) 14 +- 3 days Use of Investigational Product in the future as measured by a Likert scale score (1-2) 14 +- 3 days Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4) 14 +- 3 days Ease of Investigational Product handling as measured by a Likert scale score (1-4) 14 +- 3 days Investigational product adhesivity as measured by a Likert scale score (1-4) 14 +- 3 days Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4) 14 +- 3 days Investigational Product leakage prevention as measured by a Likert scale score (1-4) 14 +- 3 days Investigational Product overall satisfaction as measured by a Likert scale score (1-4) 14 +- 3 days Number of Participants with Adverse Events as a Measure of Safety and Tolerability baseline and 14 +- 3 days Investigational product flexibility as measured by a Likert scale score (1-4) 14 +- 3 days Feeling of Investigational Product security as measured by a Likert scale score (1-4) 14 +- 3 days Investigational product wear time 14 +- 3 days The patient will complete his patient diary after each Investigational Product removal
Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4) 14 +- 3 days Investigational Product wearing comfort as measured by a Likert scale score (1-4) 14 +- 3 days
Trial Locations
- Locations (1)
Patrick RAT
🇫🇷Dijon, France