Trial Outcomes & Findings for Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring (NCT NCT03915717)

NCT ID: NCT03915717

Last Updated: 2024-11-26

Results Overview

Surgeon evaluation of improved monitoring ability via questionnaire with likert scale

Recruitment status

TERMINATED

Target enrollment

14 participants

Primary outcome timeframe

Through study completion

Results posted on

2024-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	EchoMark / EchoSure Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	EchoMark / EchoSure Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Overall Study EchoMark Not Implanted	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EchoMark / EchoSure n=14 Participants Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Age, Continuous	64 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion

Population: Surgeon Evaluation Questionnaire was not completed, Data was not collected.

Surgeon evaluation of improved monitoring ability via questionnaire with likert scale

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Through study completion, an average of 1 year

Population: Surgeon Satisfaction Survey was not completed. Data not collected.

Surgeon evaluation of satisfaction via questionnaire with likert scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through patient stay, up to 5 days post-op

Percentage of flaps that fail

Outcome measures

Outcome measures
Measure	EchoMark / EchoSure n=8 Participants Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Flap Failure Rate	0 Flaps that Failed

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EchoMark / EchoSure n=8 Participants Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Flap Takeback Rate	0 Flaps that Required Return to the OR

SECONDARY outcome

Timeframe: Through patient stay, up to 5 days post-op

Percentage of flaps that require salvage after the baseline procedure

Outcome measures

Outcome measures
Measure	EchoMark / EchoSure n=8 Participants Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Flap Salvage Rate	0 Number of Flaps that Require Salvage

SECONDARY outcome

Timeframe: Through patient stay, up to 5 days post-op

Population: Data was not collected on hospitalization costs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EchoMark / EchoSure n=8 Participants Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure.
Time From OR Departure to Return to OR	NA Hours Time to return to OR cannot be calculated due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Through study completion, an average of 1 year

Population: The Nurse Questionnaire was not completed. Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

EchoMark / EchoSure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katy Feeny

Sonavex

Phone: 443-862-2024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place