Comparison Study of 3 Ostomy Products

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

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

Study Overview

• Status: Completed
• Conditions: Ostomy
• Intervention / Treatment: Device: Ostomy accessory

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85742
      • Independent Nurse Consultants
  • Florida
    • Jacksonville, Florida, United States, 32257
      • ET Nursing Services
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Image Specialties
  • Ohio
    • Columbus, Ohio, United States, 43222
      • ID Med Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each
Other: 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	Device: Ostomy accessory; Wearing each of the devices for 10 days each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leakage & Wear Time	Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Evaluation and comparison of the safety of three ostomy accessory products	10 days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Director: Kim Peters, ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 25, 2012

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: A739