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

Primary Purpose

Deep Vein Thrombosis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
OmniWave Endovascular System
Sponsored by
OmniSonics Medical Technologies, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Secondary Outcome Measures

    Death, clinically detectable PE, significant vessel damage in target treatment area
    Restoration and maintenance of antegrade in-line flow in target treatment area
    QOL SF-36
    Incidence of clinically significant hemolysis

    Full Information

    First Posted
    March 17, 2008
    Last Updated
    March 20, 2008
    Sponsor
    OmniSonics Medical Technologies, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00640731
    Brief Title
    Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis
    Acronym
    SONIC I
    Official Title
    Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    July 2008 (Anticipated)
    Study Completion Date
    July 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    OmniSonics Medical Technologies, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Vein Thrombosis
    Keywords
    DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    OmniWave Endovascular System
    Intervention Description
    Treatment with mechanical thrombolysis/thrombectomy
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Death, clinically detectable PE, significant vessel damage in target treatment area
    Time Frame
    through 6 months post-index procedure
    Title
    Restoration and maintenance of antegrade in-line flow in target treatment area
    Time Frame
    through 6 months post-index procedure
    Title
    QOL SF-36
    Time Frame
    through 6 months post-index procedure
    Title
    Incidence of clinically significant hemolysis
    Time Frame
    Prior to discharge

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Aruny, MD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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