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

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ClinicalTrials.gov Identifier: NCT00640731
Recruitment Status : Unknown
Verified March 2008 by OmniSonics Medical Technologies, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : March 21, 2008
Last Update Posted : March 21, 2008
Information provided by:
OmniSonics Medical Technologies, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Device: OmniWave Endovascular System Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
Study Start Date : March 2008
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: OmniWave Endovascular System
    Treatment with mechanical thrombolysis/thrombectomy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Death, clinically detectable PE, significant vessel damage in target treatment area [ Time Frame: through 6 months post-index procedure ]
  2. Restoration and maintenance of antegrade in-line flow in target treatment area [ Time Frame: through 6 months post-index procedure ]
  3. QOL SF-36 [ Time Frame: through 6 months post-index procedure ]
  4. Incidence of clinically significant hemolysis [ Time Frame: Prior to discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640731

Sponsors and Collaborators
OmniSonics Medical Technologies, Inc.
Principal Investigator: John Aruny, MD Yale University

Responsible Party: Melina Salerno, Senior Clinical Project Manager, OmniSonics Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00640731     History of Changes
Other Study ID Numbers: 2007-US-001
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: March 21, 2008
Last Verified: March 2008

Keywords provided by OmniSonics Medical Technologies, Inc.:
Peripheral Vascular Disease
Venous Thrombosis
Deep Vein Thrombosis

Additional relevant MeSH terms:
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases