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

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Neoplasm; Free Flap Transfer
• Intervention / Treatment: Device: EchoMark; Device: EchoSure

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients undergoing free flap surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale	Surgeon evaluation of improved monitoring ability via questionnaire with likert scale	Through study completion
Surgeon Evaluation of Satisfaction	Surgeon evaluation of satisfaction via questionnaire with likert scale	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap Failure Rate	Percentage of flaps that fail	Through patient stay, up to 5 days post-op
Flap Takeback Rate	Percentage of flaps that require return to the OR after the baseline procedure through 5 days post-op.	Through patient stay, up to 5 days post-op
Flap Salvage Rate	Percentage of flaps that require salvage after the baseline procedure	Through patient stay, up to 5 days post-op
Total Cost of Hospitalization		Through patient stay, up to 5 days post-op
Time From OR Departure to Return to OR	Number of hours from when the subject's baseline procedure ends until a secondary trip to the OR if required.	Through patient stay, up to 5 days post-op
Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale		Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sonavex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 13, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2019-01 (Other Identifier: NANT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No