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Comparison Study of 3 Ostomy Products

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by ConvaTec Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691729
First Posted: September 25, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ConvaTec Inc.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Leakage & Wear Time [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 10 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01691729     History of Changes
Other Study ID Numbers: A739
First Submitted: September 12, 2012
First Posted: September 25, 2012
Last Update Posted: November 14, 2012
Last Verified: September 2012