Free Flap TransferNCT03915717
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
An observational study of Free Flap Transfer and Malignant Neoplasm, run by Sonavex, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Flap Transfer, Malignant Neoplasm
- What is being tested?
- EchoMark and EchoSure
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 5 May 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing free flap surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- EchoMark, EchoSure
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoMarkDevice
EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring
EchoSureDevice
EchoSure ultrasound scans are performed to monitor the free flap
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
Surgeon evaluation of improved monitoring ability via questionnaire with likert scale
Measured: Through study completion
Surgeon Evaluation of Satisfaction
Surgeon evaluation of satisfaction via questionnaire with likert scale
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Flap Failure Rate
Percentage of flaps that fail
Measured: 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.
Measured: Through patient stay, up to 5 days post-op
Flap Salvage Rate
Percentage of flaps that require salvage after the baseline procedure
Measured: Through patient stay, up to 5 days post-op
Total Cost of Hospitalization
Measured: 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.
Measured: Through patient stay, up to 5 days post-op
Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start19 Sep 2019
- Primary completion5 May 2022
- Study completion5 May 2022
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Free Flap TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonavex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915717
- Sponsor's protocol ID
- 2019-01
- Status last verified
- Nov 2024
- First submitted
- 10 Apr 2019
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
- ClinicalTrials.gov ID
- NCT03915717
- Acronym / sponsor ID
- 2019-01
- Conditions
- Free Flap Transfer, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sonavex, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing free flap surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoMarkEchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring | Device | – |
| EchoSureEchoSure ultrasound scans are performed to monitor the free flap | Device | – |
Primary outcome
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
Time frame: Through study completion
Surgeon evaluation of improved monitoring ability via questionnaire with likert scale
Surgeon Evaluation of Satisfaction
Time frame: Through study completion, an average of 1 year
Surgeon evaluation of satisfaction via questionnaire with likert scale
6 secondary outcomes
Flap Failure Rate
Time frame: Through patient stay, up to 5 days post-op
Flap Takeback Rate
Time frame: Through patient stay, up to 5 days post-op
Flap Salvage Rate
Time frame: Through patient stay, up to 5 days post-op
Total Cost of Hospitalization
Time frame: Through patient stay, up to 5 days post-op
Time From OR Departure to Return to OR
Time frame: Through patient stay, up to 5 days post-op
Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale
Time frame: Through study completion, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Free Flap Transfer and Malignant Neoplasm, run by Sonavex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale (time frame: Through study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.