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

NCT02507726 | Completed

• 1 other identifier: OPM-G-H-1501
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Conditions

Enterostomy

Outcome Measures

Primary Outcomes (1)

• Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector

  14 +- 3 days

Secondary Outcomes (15)

• Peristomal skin evaluation with DET score scale

  baseline and 14 +- 3 days

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  baseline and 14 +- 3 days

• Investigational product wear time

  14 +- 3 days

• Investigational product adhesivity as measured by a Likert scale score (1-4)

  14 +- 3 days

• Investigational product flexibility as measured by a Likert scale score (1-4)

  14 +- 3 days

Study Arms (1)

Flexima Active Soft convexe

EXPERIMENTAL

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

Device: Flexima Active soft convexe

Interventions

Flexima Active soft convexe DEVICE

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

Flexima Active Soft convexe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 already participating in another clinical study or who have previously participated in this investigation,
• pregnant or breast-feeding woman

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (1)

Patrick RAT

Dijon, 21000, France

Location

Study Officials

• Patrick RAT, MD

  University Hospital of Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 24, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)