Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

  • STATUS
    Not Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    110
  • sponsor
    University of California, San Francisco
Updated on 8 August 2022
parathyroid
hyperparathyroidism
parathyroidectomy
parathyroid hormones
primary hyperparathyroidism
parathyroid surgery

Summary

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

Description

This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.

PRIMARY OBJECTIVES:

I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.

II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.

III. Assess the impact of PTeye on minimizing risk of post-surgical complications.

Participants will be randomized to either the experimental or control arm.

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not.

For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Participants will be follow-ed up for up to 6 months after surgery.

Details
Condition Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma, Hypercalcemia, Neoplasms, Glandular and Epithelial, Endocrine Gland Neoplasms, Adenoma, Hyperparathyroidism, Hyperparathyroidism, Primary
Treatment Parathyroid Eye (PTeye)
Clinical Study IdentifierNCT05152927
SponsorUniversity of California, San Francisco
Last Modified on8 August 2022

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