Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

NCT02602236 | Terminated

• 2 other identifiers: OPM-G-H-14012015-A00611-48
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Conditions

Colostomy

Outcome Measures

Primary Outcomes (1)

• Description of efficacy in term of type of bag deployment and leakage prevention

  After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"

  At least 1 time per day during 14±3 days

Secondary Outcomes (28)

• Peristomal skin evaluation with DET score scale

  baseline and 5±3 days and 14±3 days

• Investigational product bag deployment reason

  At each bag change during 14±3 days

• Ease of bag deployment

  14±3 days

• Ease of special bag handling

  14±3 days

• Investigational product bag ease of use of gas release button

  14±3 days

Study Arms (1)

AOS-C2000-B

EXPERIMENTAL

A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)

Device: AOS-C2000-B

Interventions

AOS-C2000-B DEVICE

1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day

AOS-C2000-B

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 with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
• Patient having a colostomy for at least 1 month
• Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
• Patient having a stoma protusion smaller than or equal to 1.5 cm
• Patient capable to apply and remove the appliance 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 the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
• Patient covered by social security

You may not qualify if:

• Patient experiencing repeated leakages with the usual pouching system
• Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
• 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)

Centre Georges François Leclerc

Dijon, 21000, France

Location

Study Officials

• Mahaut LECONTE, MD

  University Hospital of Paris - Cochin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

FR (1)