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

Terminated

• Conditions: Free Flap Transfer; Malignant Neoplasm

• Registration Number: NCT03915717
• Lead Sponsor: Sonavex, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-13
• Study First Posted: 2019-04-16
• Study Start: 2019-09-19
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Results First Submitted: 2022-10-17
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States