Clinical trial · Observational
Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
NCT07823283CI-TRIAL-00126352recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasm | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo recording of the clinical Doppler monitor via an implanted research recording device (RRD) and have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (2)
- measure
- Feasibility - record audible doppler signal tracings
- timeFrame
- Up to 30 days
- description
- 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.
- measure
- Feasibility - convert audible doppler signal tracings to stored data files
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.