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OpenTrials
Completed

NCT Number: NCT01691729

Comparison Study of 3 Ostomy Products

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

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Key information

Conditions

Ostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Independent Nurse Consultants, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ostomy accessory

Device

Wearing each of the devices for 10 days each

Primary outcomes

  1. Leakage & Wear Time

    Time frame: 10 days

    Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.

Secondary outcomes

  1. Number of adverse events

    Time frame: 10 days

    Evaluation and comparison of the safety of three ostomy accessory products

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 25, 2012
Registry last updated
Dec 7, 2022

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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