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Slow Enrollment
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing free flap surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EchoMark / EchoSure | Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EchoMark / EchoSure | Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale | Surgeon evaluation of improved monitoring ability via questionnaire with likert scale | Surgeon Evaluation Questionnaire was not completed, Data was not collected. | Posted | Through study completion |
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Adverse Event information was collected from the baseline procedure until discharge, an average of 72 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EchoMark / EchoSure | Patients undergoing free flap surgery and have an EchoMark soft tissue marking device placed and monitored with the EchoSure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katy Feeny | Sonavex | 443-862-2024 | kfeeny@sonavex.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Sep 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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 |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Surgeon Evaluation of Satisfaction | Surgeon evaluation of satisfaction via questionnaire with likert scale | Surgeon Satisfaction Survey was not completed. Data not collected. | Posted | Through study completion, an average of 1 year |
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| Secondary | Flap Failure Rate | Percentage of flaps that fail | Posted | Number | Flaps that Failed | Through patient stay, up to 5 days post-op |
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| Secondary | Flap Takeback Rate | Percentage of flaps that require return to the OR after the baseline procedure through 5 days post-op. | Posted | Number | Flaps that Required Return to the OR | Through patient stay, up to 5 days post-op |
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| Secondary | Flap Salvage Rate | Percentage of flaps that require salvage after the baseline procedure | Posted | Number | Number of Flaps that Require Salvage | Through patient stay, up to 5 days post-op |
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| Secondary | Total Cost of Hospitalization | Data was not collected on hospitalization costs. | Posted | Through patient stay, up to 5 days post-op |
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| 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. | Posted | Mean | Full Range | Hours | Through patient stay, up to 5 days post-op |
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| Secondary | Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale | The Nurse Questionnaire was not completed. Data was not collected. | Posted | Through study completion, an average of 1 year |
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| 0 |
| 8 |
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| 8 |
| 0 |
| 8 |
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