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Comparative Physiologic Technology Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01126788
First received: May 18, 2010
Last updated: November 23, 2010
Last verified: November 2010
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Glenn LaMuraglia, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01126788     History of Changes
Other Study ID Numbers: 2009P002554
Study First Received: May 18, 2010
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013