Deep Vein ThrombosisPhase 4SONIC INCT00640731
Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis
A Phase 4 study testing OmniWave Endovascular System in people with Deep Vein Thrombosis, run by OmniSonics Medical Technologies, Inc..
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- OmniWave Endovascular System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- OmniWave Endovascular System
- Keywords
- DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniWave Endovascular SystemDevice
Treatment with mechanical thrombolysis/thrombectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
Measured: Post-Index procedure
Secondary outcomes (4)
Death, clinically detectable PE, significant vessel damage in target treatment area
Measured: through 6 months post-index procedure
Restoration and maintenance of antegrade in-line flow in target treatment area
Measured: through 6 months post-index procedure
QOL SF-36
Measured: through 6 months post-index procedure
Incidence of clinically significant hemolysis
Measured: Prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OmniSonics Medical Technologies, Inc.
- Sponsor type
- University, hospital or other
- Investigators
- John Aruny, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640731
- Sponsor's protocol ID
- 2007-US-001
- Acronym
- SONIC I
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 21 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
- ClinicalTrials.gov ID
- NCT00640731
- Acronym / sponsor ID
- SONIC I / 2007-US-001
- Conditions
- Deep Vein Thrombosis
- Keywords
- DVT, Peripheral Vascular Disease, Venous Thrombosis, Deep Vein Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OmniSonics Medical Technologies, Inc.University, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniWave Endovascular SystemTreatment with mechanical thrombolysis/thrombectomy | Device | – |
Primary outcome
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
Time frame: Post-Index procedure
4 secondary outcomes
Death, clinically detectable PE, significant vessel damage in target treatment area
Time frame: through 6 months post-index procedure
Restoration and maintenance of antegrade in-line flow in target treatment area
Time frame: through 6 months post-index procedure
QOL SF-36
Time frame: through 6 months post-index procedure
Incidence of clinically significant hemolysis
Time frame: Prior to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Aruny, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OmniWave Endovascular System in people with Deep Vein Thrombosis, run by OmniSonics Medical Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System (time frame: Post-Index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2008.