Regulatory note covering a Cairo University trial on low energy laser acupuncture for tension headache in post pubertal females and its regulatory implications for device safety and evidence.
The ClinicalTrials.gov entry NCT07417644 lists two interventions: low energy laser acupuncture and a myofascial release technique, both described for tension type headaches in the specified population. The sponsor is Cairo University and as of 2026-02-19 the study is not yet recruiting.
What is the study about?
The registry describes a trial that tests two interventions: low energy laser acupuncture and a myofascial release technique. Population is post pubertal females. Sponsor is Cairo University. Status: not yet recruiting.
Interventions
- Low energy laser acupuncture
- Myofascial release technique
What is the study design and status?
The entry lists two interventions but provides limited design details. Specific elements such as randomization, control group, endpoints and sample size are not disclosed in the provided source. The sponsor remains Cairo University. The record notes not yet recruiting as of the date given.
What are regulatory implications for devices and investigators?
Because the trial involves a laser device used for acupuncture, regulatory considerations include device safety labeling training and data collection. The registry does not specify device class, required approvals, or submission status in the provided extract.
What safety considerations apply to this device based trial?
Safety implications depend on adherence to laser safety standards and clinical trial governance. No trial results are reported in the source. Readers should await formal outcomes before drawing conclusions about device performance or risk.
What does this mean for clinicians and patients?
The listing signals interest in device oriented pain management approaches. Regulators may monitor upcoming results and require appropriate training and oversight for any device used in acupuncture based studies.
FAQ
- 1) What is being studied? The trial lists two interventions: low energy laser acupuncture and a myofascial release technique for tension headaches in post pubertal females.
- 2) Who funds the trial? Cairo University is listed as sponsor.
- 3) What is the status? Not yet recruiting as of 2026-02-19.
- 4) Where can I find the trial record? It is listed on ClinicalTrials.gov under NCT07417644 with the term medical device.
- 5) Is there a results report? No results are provided in the source text.
Conclusion
Readers should track official updates from ClinicalTrials.gov to verify status and any published results. The entry underscores regulatory diligence for device based therapies in headache care and highlights the need for clear documentation on study design and safety measures.
Disclaimer
This information is intended for professionals and is not legal advice. Always verify regulatory requirements with the appropriate authorities and institutional review boards before proceeding with any device oriented research.
https://clinicaltrials.gov/study/NCT07417644?term=medical+device