Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

NCT ID: NCT02507726

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-09-30

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

Conditions

Enterostomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flexima Active Soft convexe

Flexima Active soft convexe (1 to 3 appliances per day)

Group Type: EXPERIMENTAL

Flexima Active soft convexe

Intervention Type: DEVICE

The Investigational Device will be used during 14 +- 3 days.

Interventions

Flexima Active soft convexe

The Investigational Device will be used during 14 +- 3 days.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BBraun Medical SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick RAT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Dijon

Locations

Patrick RAT

Dijon, , France

Countries

France

Other Identifiers

OPM-G-H-1501

Identifier Type: -

Identifier Source: org_study_id