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

Deep Vein Thrombosis Clinical Trial

— SONIC I  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00640731
• Other study ID #: 2007-US-001
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 17, 2008
• Last updated: March 20, 2008
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: March 2008
• Source: OmniSonics Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

Device:
• OmniWave Endovascular System
Treatment with mechanical thrombolysis/thrombectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OmniSonics Medical Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Death, clinically detectable PE, significant vessel damage in target treatment area		through 6 months post-index procedure	Yes
Secondary	Restoration and maintenance of antegrade in-line flow in target treatment area		through 6 months post-index procedure	No
Secondary	QOL SF-36		through 6 months post-index procedure	No
Secondary	Incidence of clinically significant hemolysis		Prior to discharge	Yes