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Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring

NCT03915717 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2024-11-26

Study results available
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Summary

The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.

Conditions

  • Free Flap Transfer
  • Malignant Neoplasm

Interventions

DEVICE

EchoMark

EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring

DEVICE

EchoSure

EchoSure ultrasound scans are performed to monitor the free flap

Sponsors & Collaborators

  • Sonavex, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03915717 on ClinicalTrials.gov