Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis

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

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-07-31

Brief Summary

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This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.

Detailed Description

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Conditions

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Deep Vein Thrombosis

Keywords

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DVT Peripheral Vascular Disease Venous Thrombosis Deep Vein Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OmniWave Endovascular System

Treatment with mechanical thrombolysis/thrombectomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
* Written informed consent
* Agreement to comply with follow up requirements

Exclusion Criteria

* Known R-L shunt, pulmonary A-V malformation
* Excessive tortuosity and/or sharp angulation in target treatment zone
* Isolated calf vein thrombosis
* Isolated DVT in veins peripheral to axillary vein
* Thrombus in peripheral vessel smaller than 5 mm
* Target treatment zone cannot be adequately accessed within the 100 cm working length of device

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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OmniSonics Medical Technologies, Inc.

Principal Investigators

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John Aruny, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

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2007-US-001

Identifier Type: -

Identifier Source: org_study_id