Status:
UNKNOWN
Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis
Lead Sponsor:
OmniSonics Medical Technologies, Inc.
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
Phase:
PHASE4
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 pres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00640731
Start Date
March 1 2008
End Date
July 1 2008
Last Update
March 21 2008
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