Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
NCT ID: NCT03915717
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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TERMINATED
14 participants
OBSERVATIONAL
2019-09-19
2022-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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EchoMark
EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring
EchoSure
EchoSure ultrasound scans are performed to monitor the free flap
Eligibility Criteria
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Inclusion Criteria
* Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
* Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
* Women of childbearing potential have a negative pregnancy test
Exclusion Criteria
* Patient unable to sign informed consent
* Patient participating in another investigational device or pharmacological study
* Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
18 Years
ALL
No
Sponsors
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Sonavex, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-01
Identifier Type: -
Identifier Source: org_study_id
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