Completed

Efficacy and Safety Comparison of Three Ostomy Accessory Products

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Study Aim

This study aims to compare the efficacy of three different ostomy accessory products in terms of leakage and wear time, to determine which one provides the best treatment option for ostomy patients.

What is being tested

Testing Ostomy Accessories

+ Testing Ostomy Accessories

+ Testing Ostomy Accessories

Device
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorConvaTec Inc.
Last updated: December 7, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01691729
Principal SponsorConvaTec Inc.
Last updated: December 7, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Has a stoma for at least 3 months
Has an ostomy
Is able to take care of their stoma
Is at least 18 years of age
Show More Criteria
4 exclusion criteria prevent from participating
Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion
Has participated in a clinical study within the past 30 days
Is undergoing chemotherapy or radiotherapy
Known sensitivity to any of the ostomy devices or components

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2

Group II

3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1

Group III

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product

Group IV

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product

Group 5

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2

Group 6

3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Independent Nurse Consultants

Tucson, United StatesOpen Independent Nurse Consultants in Google Maps

ET Nursing Services

Jacksonville, United States

Image Specialties

Saint Joseph, United States

ID MED Inc.

Columbus, United States
Completed4 Study Centers