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OpenTrials
Completed

NCT Number: NCT02043782

Investigation of a New 1-piece Convex Ostomy Product

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Completed

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Key information

Conditions

Stoma Ileostomy Stoma Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TFS

Søborg, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are at least 18 years of age and have full legal capacity.
  • Have had an ileostomy/colostomy for more than 3 months
  • Have used a 1-piece flat ostomy product for the last 1 month
  • Has given written Informed Consent and signed the letter of authority
  • Have an ileostomy or colostomy with a diameter of 33 mm or less
  • Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
  • Are evaluated to be suitable for a soft convex product
  • If having a colostomy: changes their product on average 2 times pr. 24h or more
  • Currently uses a bag of size medi/midi or maxi

Exclusion criteria

  • Have a loop ostomy (also called double-barrel or ostomy with two outlets).
  • Are pregnant or breastfeeding
  • Currently receiving or have within the past 2 month received radio- and/or chemotherapy
  • Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
  • Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
  • Known hypersensitivity toward any of the test products
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Use irrigation during the investigation (flush the intestine with water)
  • Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
  • If subject has a colostomy: empties the bag

Treatment and study plan

Coloplast Test

Device

Newly developed 1-piece convex ostomy product

Own product

Device

The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.

Competitor soft convex

Device

A commercially available soft convex product

Primary outcomes

  1. Degree of Leakage

    Time frame: 14 +/- 3 days

    The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
May 4, 2016

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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