Comparative Physiologic Technology Study

This study is currently recruiting participants.

Verified November 2010 by Massachusetts General Hospital

First Received on May 18, 2010. Last Updated on November 23, 2010 History of Changes

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01126788

Purpose

This study is designed to test two hypotheses:

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).
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:

MedlinePlus related topics: Peripheral Arterial Disease

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

Study Population

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

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 23, 2012