Impact of Volume Imaging Using Diagnostic Ultrasound

NCT ID: NCT01601782

Last Updated: 2018-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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Determine if volume imaging can diagnose bone, ligament, muscle injuries.

Detailed Description

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The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.

Conditions

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Bone Injuries Muscle Injuries Tendon Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Volume Imaging scan

New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.

Group Type EXPERIMENTAL

Ultrasound Scan

Intervention Type PROCEDURE

Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.

Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).

Intervention Type DEVICE

The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.

Interventions

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Ultrasound Scan

Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.

Intervention Type PROCEDURE

Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).

The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.

Intervention Type DEVICE

Other Intervention Names

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Volumetric Ultrasound 3D Ultrasound Imaging Volume Imaging

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.

Exclusion Criteria

* Unable to lie flat on ultrasound table.
* Subjects under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jon Jacobson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Jacobson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00030780

Identifier Type: -

Identifier Source: org_study_id

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