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
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.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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