Publication date context 2026 02 15. This article reports a regulatory update concerning a driving pressure adjustment protocol for high frequency jet ventilation used during tumor ablation in interventional radiology. The information comes from a ClinicalTrials.gov record that identifies Nantes University Hospital as the sponsor for study NCT07408375. The trial targets solid tumors excluding the brain and is listed as not yet recruiting on the public registry.
What this means for device and clinical teams is that a driving pressure adjustment procedure integrated with high frequency jet ventilation is under evaluation in a tumor ablation setting. The public record confirms the intervention and sponsor and provides a direct link to the official trial page.
In this article you will find a concise navigation to key sections about what is known, how the procedure may be implemented, who is sponsoring the work, and what the regulatory implications could be. For context, the primary public source is the ClinicalTrials.gov page for NCT07408375 which can be viewed here: ClinicalTrials.gov record NCT07408375. Internal reference posts on regulatory topics are also linked here: Regulatory insights and Device safety trends.
What is the study about?
Purpose
The public record describes a study that evaluates a driving pressure adjustment procedure added to high frequency jet ventilation during tumor ablation in interventional radiology. The objective is to understand how adjustments to driving pressure influence ventilation stability and the safety of the ablation procedure in solid tumors excluding CNS.
Population
Eligible conditions include solid tumors excluding central nervous system involvement, with patients undergoing tumor thermal ablation receiving HFJV support as part of the protocol.
Intervention
The intervention is a driving pressure adjustment procedure used in conjunction with high frequency jet ventilation. The summary does not specify a device model or branding in the public record.
How is the driving pressure adjustment procedure implemented?
Procedure outline
The record indicates an embedded driving pressure adjustment step within the high frequency jet ventilation workflow during tumor ablation. The goal is to assess ventilation performance and gas exchange during the ablation window.
Device involvement
The protocol centers on a high frequency jet ventilation approach with an explicit driving pressure adjustment component. The sponsor is Nantes University Hospital; the public summary does not disclose a specific device model or vendor.
Safety monitoring
With a status of not yet recruiting, the formal safety monitoring plan will be defined in the trial protocol and must align with medical device and clinical trial regulations.
Who sponsors and what is the status?
Sponsor identity
The trial is sponsored by Nantes University Hospital, a major French center for interventional radiology research and execution.
Current recruitment status
The registry lists the study as not yet recruiting, indicating that participant enrollment has not started.
Regulatory context
The description implies a procedural intervention that engages a medical device component, which will require adherence to applicable regulatory paths for devices and clinical trial governance.
What are the regulatory implications?
Intended use and safety
Clear statements of intended use and safety claims are essential for any device related procedure in the interventional radiology setting. The driving pressure adjustment protocol operating with high frequency jet ventilation will require documented risk management and verification of performance.
Market and labeling considerations
If future results demonstrate favorable safety and performance, regulatory considerations for labeling and guidance may follow under applicable medical device regulations and guidance.
Data and oversight
The ClinicalTrials.gov record provides the official data about status and scope. Registries require ongoing updates and transparent reporting to support regulatory oversight.
Conclusion and next steps
This entry notes a regulatory study evaluating a driving pressure adjustment procedure within high frequency jet ventilation for tumor ablation. The not yet recruiting status signals early stage activity. Regulators and manufacturers should track the registry for amendments, potential results and any implications for device development in interventional radiology.
Frequently asked questions
- 1. What is the focus of the trial NCT07408375? A regulatory assessment of a driving pressure adjustment during high frequency jet ventilation used in tumor ablation within interventional radiology.
- 2. Where is the sponsor located and what is the trial status? Nantes University Hospital is the sponsor; the record shows not yet recruiting.
- 3. Where can the official record be found? On ClinicalTrials.gov at NCT07408375; see the link in the article for access.
- 4. Are there internal references for regulatory topics? Yes, regulatory insights and device safety trends linked in the article.
Disclaimer: This article is intended for healthcare professionals and regulators. It is not legal advice.
https://clinicaltrials.gov/study/NCT07408375?term=medical+device