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Comparative Physiologic Technology Study

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 November 2010 by Massachusetts General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126788
First Posted: May 20, 2010
Last Update Posted: November 24, 2010
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:
Massachusetts General Hospital
  Purpose

This study is designed to test two hypotheses:

  1. The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab testing system in a group of patients referred for evaluation of PAD of the limbs when performed by a Registered Vascular Technologist (RVT).
  2. The PADnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the PADnet+ system but are not vascular technologists nor hold the RVT certification.

Condition
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Physiologic Technology Study

Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
PADnet + testing
Parks Flo-lab Test

  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 to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients referred to the MGH Vascular Labs for diagnostic testing for PAD
Criteria

Inclusion Criteria:

  • All patients referred to the MGH Vascular Labs for diagnostic testing for PAD

Exclusion Criteria:

  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): NCT01126788


Locations
United States, Massachusetts
Massachsetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Glenn LaMuraglia, MD    617-726-6997    glamuraglia@partners.org   
Contact: Joseph A LoPiccolo    617-724-5200    jlopiccolo@partners.org   
Principal Investigator: Glenn LaMuraglia, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Glenn LaMuraglia, MD Massachusetts General Hospital
  More Information

Responsible Party: Glenn LaMuraglia, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01126788     History of Changes
Other Study ID Numbers: 2009P002554
First Submitted: May 18, 2010
First Posted: May 20, 2010
Last Update Posted: November 24, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases