Recruiting

Monitoring Free Flaps

Sponsor:

Mayo Clinic

Code:

NCT07823283

Conditions

Head and Neck Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief 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. 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

Study ID

NCT07823283

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo recording of the clinical Doppler monitor via an implanted research recording device (RRD) and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Feasibility - record audible doppler signal tracings [ Time Frame: Up to 30 days ]
  • Feasibility - convert audible doppler signal tracings to stored data files [ Time Frame: Up to 30 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Colleen Dickman

507-284-1231

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Colleen Dickman

507-284-1231

Principal Investigator:

Kathryn M. Van Abel, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.