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OpenTrials
Completed

NCT Number: NCT01994902

Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

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

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TFS, Søborg, Denmark

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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.
  • Has had an ileostomy for at least 3 months.
  • Has used a convex ostomy product for the last month.
  • Has given signed informed consent.
  • Has experienced seeping under the baseplate at least three times during the last two weeks.
  • Currently using a SenSura Convex product with midi, maxi or magnum bags.
  • Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
  • Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion criteria

  • Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
  • Are pregnant or breastfeeding.
  • Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
  • Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
  • Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
  • Are currently participating in another clinical intervention study or have previously participated in this one.
  • Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
  • Has known hypersensitivity toward the test product.

Treatment and study plan

Coloplast test product

Device

The Coloplast test product is a newly developed ostomy appliance

SenSura Convex Light

Device

The comparator product is SenSura Convex Light, which is CE-marked and commercially available.

Other names: SenSura

Primary outcomes

  1. Degree of Leakage

    Time frame: 28 +/- 3 days

    The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Jan 12, 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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