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Completed

NCT Number: NCT03108105

Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

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

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Key information

Conditions

Colostomy Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elie CHOUILLARD

Poissy, 78100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 a flat ostomy appliance
  • 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 evaluation 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

Treatment and study plan

AOS-C2001-B

Device

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)

Primary outcomes

  1. Description of efficacy in terms of stool collection 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 4-point scale the type of capsule cap cover removal

  2. Description of efficacy in terms of stool collection 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 4-point scale the level of leakage

Sponsors and collaborators

Lead sponsor

BBraun Medical SAS

Industry

Registry information

Official study title

Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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