Comparison Study of 3 Ostomy Products

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Convatec

Status

Completed

Conditions

Ostomy

Treatments

Device: Ostomy accessory

Study type

Interventional

Funder types

Industry

Identifiers

NCT01691729
A739

Details and patient eligibility

About

To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.

Full description

The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Has an ostomy
  • Is at least 18 years of age
  • Has a stoma for at least 3 months
  • Other than thier ostomy is considered to have a healthy/stable health
  • Is able to take care of their stoma

Exclusion criteria

  • Known sensitivity to any of the ostomy devices or components
  • Is undergoing chemotherapy or radiotherapy
  • Has participated in a clinical study within the past 30 days
  • Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

26 participants in 6 patient groups

Ostomy 1
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
Treatment:
Device: Ostomy accessory
Ostomy 2
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1
Treatment:
Device: Ostomy accessory
Ostomy 3
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product
Treatment:
Device: Ostomy accessory
Ostomy 4
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product
Treatment:
Device: Ostomy accessory
Ostomy 5
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2
Treatment:
Device: Ostomy accessory
Ostomy 6
Other group
Description:
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1
Treatment:
Device: Ostomy accessory

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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