A new randomized clinical trial seeks to evaluate the performance of two videolaryngoscopes—Laringocel® and C-MAC®—in achieving first-attempt intubation success. Scheduled for future recruitment, the study targets adult patients undergoing elective surgeries under general anesthesia. Clinical teams, regulatory professionals, and medical device stakeholders may find these findings impactful as they continue developing and assessing airway management technologies.
In this article:
- What changed?
- Trial details
- Clinical and regulatory insights
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement link
What changed?
As of November 20, 2025, ClinicalTrials.gov listed a newly designed trial under the sponsorship of Mario Zamudio. While recruitment has not yet started, this study signals advancements in videolaryngoscope technologies aimed at improving the success of airway management during elective surgeries. Two devices—Laringocel® and C-MAC®—will be tested side by side for first-attempt endotracheal intubation performance.
Trial details
Who is conducting the investigation?
The research is sponsored by Mario Zamudio and will be conducted under strict regulatory and ethical oversight, though specific trial locations and additional collaborators are not named in the given preliminary record.
What is the intervention?
Patients undergoing general anesthesia will receive intubation facilitated by either the Laringocel® or C-MAC® videolaryngoscope. For anesthesia induction, clinicians will deliver intravenous propofol and rocuronium, followed by maintenance using inhaled agents sevoflurane and nitrous oxide.
What outcomes are measured?
The primary endpoint is first-attempt success in intubating the trachea, a critical metric for assessing device effectiveness in airway management.
Clinical and regulatory insights
How does this trial align with regulatory priorities?
Clinical evidence for medical devices plays a central role under MDR Annex XIV. This trial embodies regulatory principles by systematically evaluating intended performance, safety, and potential adverse event profiles for two devices targeting a crucial medical procedure.
Why focus on videolaryngoscopes?
Videolaryngoscopes have revolutionized airway management by providing enhanced visualization during intubation. Comparative data on models like Laringocel® and C-MAC® help professionals make informed decisions about technology use in clinical practice.
Frequently Asked Questions
- When will recruitment begin?
Recruitment has not started as of this announcement. Updates may be available on ClinicalTrials.gov closer to the enrollment period. - Who is eligible to participate?
Adult patients undergoing elective surgeries under general anesthesia may be eligible, pending specific inclusion and exclusion criteria. - How can stakeholders track progress?
Stakeholders can monitor the study’s unique identifier NCT07239141 on ClinicalTrials.gov for new updates and recruitment schedules.
Conclusion
This study promises significant insights into videolaryngoscope performance under clinical conditions. By evaluating intubation success rates, the findings could improve decision-making in anesthesia practices while supporting regulatory compliance for device manufacturers. Regulatory and clinical teams should monitor updates closely as the trial progresses.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Always consult qualified professionals for regulatory guidance.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07239141?term=medical+device