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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915717
• Other study ID #: 2019-01
• Status: Recruiting
• Start date: September 19, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Sonavex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Free Flap Transfer
• Malignant Neoplasm
• Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sonavex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon evaluation of improved monitoring ability via questionnaire with likert scale		Through study completion, an average of 1 year
Primary	Surgeon evaluation of satisfaction via questionnaire with likert scale		Through study completion, an average of 1 year
Secondary	Flap failure rate		Through patient stay, up to 5 days post-op
Secondary	Flap takeback rate		Through patient stay, up to 5 days post-op
Secondary	Flap salvage rate		Through patient stay, up to 5 days post-op
Secondary	Total cost of hospitalization		Through patient stay, up to 5 days post-op
Secondary	Time from OR departure to return to OR		Through patient stay, up to 5 days post-op
Secondary	Nurse evaluation of improved monitoring via questionnaire with likert scale		Through study completion, an average of 1 year