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

Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640731

Acronym

SONIC I

Enrollment

Registered

2008-03-21

Start date

2008-03-31

Completion date

2008-07-31

Last updated

2008-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis

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.

Interventions

DEVICEOmniWave Endovascular System

Treatment with mechanical thrombolysis/thrombectomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System	Post-Index procedure

Secondary

Measure	Time frame
Death, clinically detectable PE, significant vessel damage in target treatment area	through 6 months post-index procedure
Restoration and maintenance of antegrade in-line flow in target treatment area	through 6 months post-index procedure
QOL SF-36	through 6 months post-index procedure
Incidence of clinically significant hemolysis	Prior to discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026