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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
OmniSonics Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00640731
First received: March 17, 2008
Last updated: March 20, 2008
Last verified: March 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death, clinically detectable PE, significant vessel damage in target treatment area [ Time Frame: through 6 months post-index procedure ] [ Designated as safety issue: Yes ]
  • Restoration and maintenance of antegrade in-line flow in target treatment area [ Time Frame: through 6 months post-index procedure ] [ Designated as safety issue: No ]
  • QOL SF-36 [ Time Frame: through 6 months post-index procedure ] [ Designated as safety issue: No ]
  • Incidence of clinically significant hemolysis [ Time Frame: Prior to discharge ] [ Designated as safety issue: Yes ]

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
    Other Name: OmniWave Endovascular System
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640731

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

No publications provided

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
Study First Received: March 17, 2008
Last Updated: March 20, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013