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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602236
Recruitment Status : Terminated (Investigational product needs improvements)
First Posted : November 11, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
BBraun Medical SAS

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

Condition or disease Intervention/treatment Phase
Colostomy Device: AOS-C2000-B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
Study Start Date : November 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: AOS-C2000-B
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
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day




Primary Outcome Measures :
  1. Description of efficacy in term of type of bag deployment and leakage prevention [ Time Frame: At least 1 time per day during 14±3 days ]
    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"


Secondary Outcome Measures :
  1. Peristomal skin evaluation with DET score scale [ Time Frame: baseline and 5±3 days and 14±3 days ]
  2. Investigational product bag deployment reason [ Time Frame: At each bag change during 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  3. Ease of bag deployment [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  4. Ease of special bag handling [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  5. Investigational product bag ease of use of gas release button [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  6. Ease of control of gas release button [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  7. General impression about the investigational device before use [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  8. Investigational device wearing comfort [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  9. Investigational device flexibility [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  10. Investigational device discretion [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  11. Ease of base plate handling [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  12. Investigational device adhesivity during wear time [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  13. Investigational device filter performance with deployed bag [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  14. Investigational device filter performance with undeployed bag [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  15. Efficacy of Investigational device gas release button [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  16. Noise during Investigational device wear time [ Time Frame: 14±3 days ]
    Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)

  17. Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device [ Time Frame: 14±3 days ]
  18. Overall security feeling questionnaire with the Investigational device [ Time Frame: 14±3 days ]
  19. Overall satisfaction questionnaire with the Investigational device [ Time Frame: 14±3 days ]
  20. Overall satisfaction questionnaire regarding bag deployment of the Investigational device [ Time Frame: 14±3 days ]
  21. Overall satisfaction questionnaire with cap cover of the Investigational device [ Time Frame: 14±3 days ]
  22. General impression about body image during use of the investigational product [ Time Frame: 14±3 days ]
    (4-points very satisfying to not at all satisfying)

  23. Assessment questionnaire of willingness to use and the frequency of use in the future [ Time Frame: 14±3 days ]
  24. Assessment of the investigational device wear time [ Time Frame: 14±3 days ]
  25. Assessment questionnaire preference between the investigational device and usual appliance [ Time Frame: 14±3 days ]
  26. Assessment of use of accessories [ Time Frame: At each bag change during 14±3 days ]
    Choice between some accessories

  27. Assessment of the quality of life with Stoma-QoL questionnaire [ Time Frame: At baseline, at 5±3 days and 14±3 days ]
  28. Number of participants with Adverse Event as a measure of safety and tolerability [ Time Frame: At baseline, at 5±3 days and 14±3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient experiencing repeated leakages with the usual pouching system
  • Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602236


Locations
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France
Centre Georges François Leclerc
Dijon, France, 21000
Sponsors and Collaborators
BBraun Medical SAS
Investigators
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Principal Investigator: Mahaut LECONTE, MD University Hospital of Paris - Cochin
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Responsible Party: BBraun Medical SAS
ClinicalTrials.gov Identifier: NCT02602236    
Other Study ID Numbers: OPM-G-H-1401
2015-A00611-48 ( Other Identifier: FRENCH HEALTH AUTORITY )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017