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Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

NCT02889952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 297

Last updated 2016-09-07

No results posted yet for this study

Summary

This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT).

It compares two groups of consecutive patients who underwent TT associated or not to lymph node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.

Conditions

Interventions

DEVICE

Near infrared camera (NIR)

Surgical field was examined with NIR, during a few minutes (\<5') with room lights switched off, to avoid parasite lights, then conventional open thyroidectomy was resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, were checked visually. NIR consisted of a 750 nm class 1 laser excitation, with a power \<20mW/cm2 (5 times less than the limit of 100mw/cm2, fixed by the international norm IEC 60601-2-41). It was provided by the Fluobeam® camera, which was inserted into a sterile cover and hold at a 15-20 cm distance from the patient. The system has an FDA 510(k) authorization for clinical use in parathyroid surgery and a European Community certification (Class 1 device).

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER

  • Hôpital Européen Marseille

    lead OTHER

Principal Investigators

  • Fares BENMILOUD, MD · Hopital Europeen Marseille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889952 on ClinicalTrials.gov