Comparison Study of 3 Ostomy Products

NCT ID: NCT01691729

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ostomy 1

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

Group Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Ostomy 2

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 Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Ostomy 3

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 Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Ostomy 4

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 Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Ostomy 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 Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Ostomy 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

Group Type OTHER

Ostomy accessory

Intervention Type DEVICE

Wearing each of the devices for 10 days each

Interventions

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Ostomy accessory

Wearing each of the devices for 10 days each

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ConvaTec Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Peters

Role: STUDY_DIRECTOR

ConvaTec Inc.

Locations

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Independent Nurse Consultants

Tucson, Arizona, United States

Site Status

ET Nursing Services

Jacksonville, Florida, United States

Site Status

Image Specialties

Saint Joseph, Missouri, United States

Site Status

ID MED Inc.

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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A739

Identifier Type: -

Identifier Source: org_study_id

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