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NCT Number: NCT07823283

Continuous Monitoring of Microvascular Anastomoses: An Observational Trial

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.

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Key information

Conditions

Head and Neck Neoplasm Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Feasibility - convert audible data to visual signal to a visual signal

    Time frame: Up to 30 days

    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.

Other outcomes

  1. AI algorithm

    Time frame: Up to 2 years

    Ability to build a predictive artificial intelligence (AI) algorithm for identifying high-risk or compromised flaps using a neural network.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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