Comparison Study of 3 Ostomy Products

Ostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691729
• Other study ID #: A739
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2022
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

Device:
• Ostomy accessory
Wearing each of the devices for 10 days each

Locations

Country	Name	City	State
United States	ID MED Inc.	Columbus	Ohio
United States	ET Nursing Services	Jacksonville	Florida
United States	Image Specialties	Saint Joseph	Missouri
United States	Independent Nurse Consultants	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage & Wear Time	Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.	10 days
Secondary	Number of adverse events	Evaluation and comparison of the safety of three ostomy accessory products	10 days