Free Flap Transfer, Malignant Neoplasm
Conditions
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.
Interventions
DEVICEEchoMark
EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring
DEVICEEchoSure
EchoSure ultrasound scans are performed to monitor the free flap
Sponsors
Sonavex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Flap Failure Rate | Through patient stay, up to 5 days post-op | Percentage of flaps that fail |
| Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale | Through study completion, an average of 1 year | — |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EchoMark / EchoSure Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | EchoMark Not Implanted | 6 |
Baseline characteristics
| Characteristic | EchoMark / EchoSure |
|---|---|
| Age, Continuous | 64 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
Surgeon evaluation of improved monitoring ability via questionnaire with likert scale
Time frame: Through study completion
Population: Surgeon Evaluation Questionnaire was not completed, Data was not collected.
Primary
Surgeon Evaluation of Satisfaction
Surgeon evaluation of satisfaction via questionnaire with likert scale
Time frame: Through study completion, an average of 1 year
Population: Surgeon Satisfaction Survey was not completed. Data not collected.
Secondary
Flap Failure Rate
Percentage of flaps that fail
Time frame: Through patient stay, up to 5 days post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark / EchoSure | Flap Failure Rate | 0 Flaps that Failed |
Secondary
Flap Salvage Rate
Percentage of flaps that require salvage after the baseline procedure
Time frame: Through patient stay, up to 5 days post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark / EchoSure | Flap Salvage Rate | 0 Number of Flaps that Require Salvage |
Secondary
Flap Takeback Rate
Percentage of flaps that require return to the OR after the baseline procedure through 5 days post-op.
Time frame: Through patient stay, up to 5 days post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark / EchoSure | Flap Takeback Rate | 0 Flaps that Required Return to the OR |
Secondary
Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale
Time frame: Through study completion, an average of 1 year
Population: The Nurse Questionnaire was not completed. Data was not collected.
Secondary
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.
Time frame: Through patient stay, up to 5 days post-op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EchoMark / EchoSure | Time From OR Departure to Return to OR | NA Hours |
Secondary
Total Cost of Hospitalization
Time frame: Through patient stay, up to 5 days post-op
Population: Data was not collected on hospitalization costs.