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Comparison Study of 3 Ostomy Products

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01691729
First received: September 12, 2012
Last updated: November 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Ostomy
 Device: Ostomy accessory

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products

Resource links provided by NLM:

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Leakage & Wear Time [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691729

Locations
United States, Arizona
Independent Nurse Consultants
Tucson, Arizona, United States, 85742
United States, Florida
ET Nursing Services
Jacksonville, Florida, United States, 32257
United States, Missouri
Image Specialties
St. Joseph, Missouri, United States, 64506
United States, Ohio
ID MED Inc.
Columbus, Ohio, United States, 43222
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Kim Peters ConvaTec Inc.
  More Information

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01691729     History of Changes
Other Study ID Numbers: A739
Study First Received: September 12, 2012
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013