Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02507726
Other study ID # OPM-G-H-1501
Secondary ID
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


Read more »

Study Design

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


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03572673 - Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy N/A
Recruiting NCT03469609 - Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial) N/A
Completed NCT04966286 - The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy N/A
Completed NCT02811926 - Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy N/A
Active, not recruiting NCT06392646 - Construction and Validation of a Postoperative Self-management Education Program for Elderly Patients With Enterostomies N/A
Completed NCT02713776 - Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment Phase 2
Completed NCT02812095 - Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy N/A
Recruiting NCT05373888 - Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients