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Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

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Coloplast

Status

Completed

Conditions

Ileostomy - Stoma

Treatments

Device: Test product
Device: SenSura

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Be able to handle the bags themselves
  4. Have an ileostomy with a diameter between 15 and 55 mm
  5. Have had their ileostomy for at least 3 months
  6. Currently use a 1-piece flat ostomy appliance with open bag
  7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
  8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
  9. Must be able and willing to use custom cut products
  10. Accept to test two 1-piece products within the study period

Exclusion criteria

  1. Use irrigation during the study period (flush the intestines with water)
  2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
  3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
  4. Are pregnant or breastfeeding
  5. Participating in other interventional clinical investigations or have previously participated in this investigation
  6. Currently using a ostomy belt
  7. Currently using extended wear product
  8. Have a loop ileostomy
  9. Known hypersensitivity towards any of the test products
  10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

First Test product; then SenSura
Experimental group
Description:
The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available.
Treatment:
Device: Test product
Device: SenSura
First SenSura, Then Test product
Active Comparator group
Description:
The subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.
Treatment:
Device: Test product
Device: SenSura

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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