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

Sonavex

Status: Terminated

Conditions: Malignant Neoplasm; Free Flap Transfer

Treatments: Device: EchoMark; Device: EchoSure

Study type: Observational

Funder types: Industry

Identifiers

NCT03915717

2019-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• 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

• Age <18 years old
• 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.

Trial design