Comparative Physiologic Technology Study

NCT ID: NCT01126788

Last Updated: 2010-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PADnet + testing

No interventions assigned to this group

Parks Flo-lab Test

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Glenn LaMuraglia, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachsetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Glenn LaMuraglia, MD

Role: primary

Joseph A LoPiccolo

Role: backup

Other Identifiers

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2009P002554

Identifier Type: -

Identifier Source: org_study_id