Continuous Monitoring of Microvascular Anastomoses: An Observational Trial

NCT07823283 | Recruiting

• 3 other identifiers: MC260703NCI-2026-0618226-005423
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 30 days

Secondary Outcomes (1)

• Feasibility - convert audible data to visual signal to a visual signal

  Up to 30 days

Other Outcomes (1)

• AI algorithm

  Up to 2 years

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo free flap surgery with an implantable doppler

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Kathryn M. Van Abel, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Colleen Dickman

CONTACT

507-284-1231

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)