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

NCT03915717 | Terminated Results FDA Device

• 1 other identifier: 2019-01
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Free Flap Transfer; Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Flap Failure Rate

  Through patient stay, up to 5 days post-op

• Flap Takeback Rate

  Through patient stay, up to 5 days post-op

• Flap Salvage Rate

  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

  Through patient stay, up to 5 days post-op

Interventions

EchoMark DEVICE

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

EchoSure DEVICE

EchoSure ultrasound scans are performed to monitor the free flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing free flap surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonavex, Inc.: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Katy Feeny
• Organization: Sonavex

kfeeny@sonavex.com

443-862-2024

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: September 19, 2019
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Locations

US (1)