A new ultrasound imaging study from Duke University evaluates head and neck anatomy in healthy volunteers to inform device performance and safety.
Publication date is February 13 2026 and the record indicates not yet recruiting at this time.
This article summarizes the study details, who should track regulatory relevance, and what clinicians and developers should watch for in terms of device performance, safety signals, and study scope.
The clinical trial record describes an intervention using ultrasonography as a diagnostic test for imaging the head, neck and airway. The target population is healthy volunteers, which means the work focuses on early evaluation rather than patient care. The sponsor is Duke University and the status is not yet recruiting. A linked external page provides the official record for this trial.
Source link: ClinicalTrials.gov record NCT07406061.
In this article the navigation offers quick access to the main topics and keeps discussion grounded in regulatory facts. The content also notes that this is an early stage study and not a finished device clearance.
In this article
What changed?
The ClinicalTrials.gov entry for NCT07406061 lists an ultrasound based imaging study of the head, neck and airway. The condition is healthy. The intervention is ultrasonography as a diagnostic test. The sponsor is Duke University. Status is not yet recruiting. This entry reflects an early stage evaluation of a diagnostic device concept rather than a finished regulatory clearance. The page notes the sponsor as the source of funding and oversight and signals early inquiry rather than final results.
The record also emphasizes that the study centers on non disease contexts and uses ultrasound imaging to characterize feasibility rather than establish proof of performance. No clinical outcomes are reported at this stage. External reference to the official record is included for traceability and transparency.
External reference: ClinicalTrials.gov record NCT07406061.
For broader context see related posts on our site about ultrasound trends in head and neck imaging Ultrasound trends in head and neck imaging and regulatory considerations for diagnostic device trials Regulatory device trial considerations.
Who is affected?
This record will be of interest to device developers, medical imaging teams and regulatory professionals. It identifies healthy volunteers as the study population, which means results will inform base line imaging standards rather than patient outcomes. The sponsor is Duke University and the trial status remains not yet recruiting, indicating this is groundwork rather than an imminent product submission.
Clinicians who use ultrasound to evaluate head neck regions may monitor this work for future memory and practice implications. Regulatory teams will want to align expectations with the early stage nature of the record and plan for future updates as the project progresses.
For broader context see related posts on our site about ultrasound trends in head and neck imaging Ultrasound trends in head and neck imaging and regulatory considerations for diagnostic device trials Regulatory device trial considerations.
How will safety and performance be assessed?
The entry states ultrasonography will be used as a diagnostic test. Specific endpoints, sample size and results are not provided in the current record. The material reflects an early stage exploration rather than data on device performance in a regulated setting. The narrative suggests attention to imaging quality and reliability as part of feasibility checks rather than a full validation plan.
Stakeholders should expect future updates that define imaging criteria, reproducibility measures and any safety signals observed during volunteer imaging sessions. The current record does not imply a final performance profile or clearance status.
What are the regulatory implications?
Because this is not yet recruiting and the population is healthy volunteers, the record documents early stage work. It does not imply clearance or approval for any device. Regulators will anticipate detailed risk management, labeling considerations and surveillance planning if the project advances toward a real product. Readers should track MDR Annex XIV references and align any future submissions with the intended use and safety expectations described in later updates.
FAQ
- 1. What is the purpose of this study? The study uses ultrasound imaging to examine the head and neck region in healthy volunteers as part of early device evaluation.
- 2. Who is conducting the study? The sponsor listed is Duke University and the study is registered on ClinicalTrials.gov.
- 3. What technology is used? Ultrasonography for diagnostic imaging of the head, neck and airway.
- 4. What is the current status? The trial is not yet recruiting at this time.
In summary this early ultrasound study from Duke signals ongoing device evaluation in a healthy population. Regulatory watchers should monitor updates on the ClinicalTrials.gov page and assess any later findings for device claims and safety considerations.
This article is prepared for professionals and does not constitute legal advice. It is intended for informational purposes only and reflects the information available from the source text.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07406061?term=medical+device