Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis (SONIC I)

March 20, 2008 updated by: OmniSonics Medical Technologies, Inc.

Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
Time Frame: Post-Index procedure
Post-Index procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Death, clinically detectable PE, significant vessel damage in target treatment area
Time Frame: through 6 months post-index procedure
through 6 months post-index procedure
Restoration and maintenance of antegrade in-line flow in target treatment area
Time Frame: through 6 months post-index procedure
through 6 months post-index procedure
QOL SF-36
Time Frame: through 6 months post-index procedure
through 6 months post-index procedure
Incidence of clinically significant hemolysis
Time Frame: Prior to discharge
Prior to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OmniSonics Medical Technologies, Inc.

Investigators

  • Principal Investigator: John Aruny, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

July 1, 2008

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2008

Last Update Submitted That Met QC Criteria

March 20, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-US-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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