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

OmniSonics Medical Technologies

Status and phase

Unknown

Phase 4

Conditions

Deep Vein Thrombosis

Treatments

Device: OmniWave Endovascular System

Study type

Interventional

Funder types

Other

Identifiers

NCT00640731

2007-US-001

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Volunteers

No 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