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

Enterostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507726
• Other study ID #: OPM-G-H-1501
• Status: Completed
• Phase: N/A
• First received: July 3, 2015
• Last updated: September 22, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterostomy

Intervention

Device:
• Flexima Active soft convexe
The Investigational Device will be used during 14 +- 3 days.

Locations

Country	Name	City	State
France	Patrick RAT	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector		14 +- 3 days	No
Secondary	Peristomal skin evaluation with DET score scale		baseline and 14 +- 3 days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		baseline and 14 +- 3 days	Yes
Secondary	Investigational product wear time	The patient will complete his patient diary after each Investigational Product removal	14 +- 3 days	No
Secondary	Investigational product adhesivity as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Investigational product flexibility as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Investigational product conformability as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Ease of Investigational Product handling as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Investigational Product wearing comfort as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Investigational Product leakage prevention as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Feeling of Investigational Product security as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Investigational Product overall satisfaction as measured by a Likert scale score (1-4)		14 +- 3 days	No
Secondary	Use of Investigational Product in the future as measured by a Likert scale score (1-2)		14 +- 3 days	No