Safety and Efficacy Study of OmniWave Endovascular System... | NCT00640731

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

NCT00640731

Sponsor

OmniSonics Medical Technologies, Inc.

Status

Unknown status

Last Update Posted

Mar 21, 2008Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Deep Vein Thrombosis

Interventions

OmniWave Endovascular System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2008Estimated

Completion Date

Jul 2008Estimated

First Submitted Date

Mar 17, 2008

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2008

Last Update Posted Date

Mar 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OmniWave Endovascular System	Device	Treatment with mechanical thrombolysis/thrombectomy

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Aruny, MD	Yale University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided