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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by OmniSonics Medical Technologies, Inc..
Recruitment status was:  Enrolling by invitation
Information provided by:
OmniSonics Medical Technologies, Inc. Identifier:
First received: March 17, 2008
Last updated: March 20, 2008
Last verified: March 2008
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 Intervention Phase
Deep Vein Thrombosis
Device: OmniWave Endovascular System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by OmniSonics Medical Technologies, Inc.:

Primary Outcome Measures:
  • 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:
  • Death, clinically detectable PE, significant vessel damage in target treatment area [ Time Frame: 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 ]
  • QOL SF-36 [ Time Frame: through 6 months post-index procedure ]
  • Incidence of clinically significant hemolysis [ Time Frame: Prior to discharge ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OmniWave Endovascular System
    Treatment with mechanical thrombolysis/thrombectomy

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00640731

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

Responsible Party: Melina Salerno, Senior Clinical Project Manager, OmniSonics Medical Technologies, Inc. Identifier: NCT00640731     History of Changes
Other Study ID Numbers: 2007-US-001
Study First Received: March 17, 2008
Last Updated: March 20, 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 processed this record on May 25, 2017