Head and Neck NeoplasmNCT07823283
Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
An observational study of Head and Neck Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to see whether signals from a device that monitors blood flow through the free flap can be recorded and converted from an audible signal, like a heartbeat, into a visual signal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo free flap surgery with an implantable doppler
Who may be able to join
- Scheduled for free flap surgery and planned to have an implanted doppler monitor
- Arterial Doppler waveforms available for analysis
- Able and willing to sign consent and return for clinical follow up
- Age ≥ 18 years
Who cannot join
- Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colleen Dickman contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Colleen Dickman, 507-284-1231
About this study
This study is being done to see whether signals from a device that monitors blood flow through the free flap can be recorded and converted from an audible signal, like a heartbeat, into a visual signal. Researchers plan to use this information to ultimately help surgeons and care teams monitor free flaps to try to prevent flap failure.
- Conditions
- Head and Neck Neoplasm
- Being tested
- Non-Interventional Study
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo recording of the clinical Doppler monitor via an implanted research recording device (RRD) and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - record audible doppler signal tracings
Ability to record a minimum of 2 audible doppler signal tracings from the implantable doppler per 24 hours for a minimum of one 24 hour period for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed research recording device (RRD) to record and convert recorded signals into various visual formats. Recordings will be observed by study staff to determine whether auditory acuity matches expected signals.
Measured: Up to 30 days
Feasibility - convert audible doppler signal tracings to stored data files
Ability to convert the recorded doppler signal tracings to stored data files for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats.
Measured: Up to 30 days
Secondary outcomes (1)
Feasibility - convert audible data to visual signal to a visual signal
Ability to convert a minimum of 80% of the audible data files to a visual signal. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats. Visual displays will be observed by study staff to confirm the display matches the expected form, as informed by prior experience/literature with doppler studies of peripheral vasculature. The specific methods for visualization will include a multimodal approach that includes Doppler signal time-series waveform, spectrogram, and Fourier Transform.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start17 Sep 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Van Abel, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823283
- Sponsor's protocol ID
- MC260703
- Other IDs
- NCI-2026-06182, 26-005423
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
- ClinicalTrials.gov ID
- NCT07823283
- Acronym / sponsor ID
- MC260703
- Conditions
- Head and Neck Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see whether signals from a device that monitors blood flow through the free flap can be recorded and converted from an audible signal, like a heartbeat, into a visual signal. Researchers plan to use this information to ultimately help surgeons and care teams monitor free flaps to try to prevent flap failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo recording of the clinical Doppler monitor via an implanted research recording device (RRD) and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo free flap surgery with an implantable doppler
Key inclusion criteria (4 listed)
- Scheduled for free flap surgery and planned to have an implanted doppler monitor
- Arterial Doppler waveforms available for analysis
- Able and willing to sign consent and return for clinical follow up
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration
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 |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Feasibility - record audible doppler signal tracings
Time frame: Up to 30 days
Ability to record a minimum of 2 audible doppler signal tracings from the implantable doppler per 24 hours for a minimum of one 24 hour period for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed research recording device (RRD) to record and convert recorded signals into various visual formats. Recordings will be observed by study staff to determine whether auditory acuity matches expected signals.
Feasibility - convert audible doppler signal tracings to stored data files
Time frame: Up to 30 days
Ability to convert the recorded doppler signal tracings to stored data files for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats.
1 secondary outcome
Feasibility - convert audible data to visual signal to a visual signal
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Colleen Dickman contact
Kathryn M. Van Abel, MD principal investigator
Mayo Clinic in Rochester
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 Head and Neck Neoplasm, run by Mayo Clinic 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 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - record audible doppler signal tracings (time frame: Up to 30 days). 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 21 Sep 2026.