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NCT01126788 Clinical Trial

Comparative Physiologic Technology Study

Peripheral Arterial Disease Clinical Trial

Official title:
Comparative Physiologic Technology Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01126788
Other study ID # 2009P002554
Secondary ID
Status Recruiting
Phase N/A
First received May 18, 2010
Last updated November 23, 2010
Start date December 2009
Est. completion date December 2011

Study information
Verified date November 2010
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachsetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

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