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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parathyroid Diseases Parathyroid Dysfunction Parathyroid Neoplasms Parathyroid Adenoma Hypercalcemia Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Adenoma Hyperparathyroidism Hyperparathyroidism, Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Only participants will be masked to the intervention

Study Groups

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Parathyroid Eye (PTeye)

For patients assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.

Group Type EXPERIMENTAL

Parathyroid Eye (PTeye)

Intervention Type DEVICE

Intraoperative Tool

Usual Standard of Care

The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parathyroid Eye (PTeye)

Intraoperative Tool

Intervention Type DEVICE

Other Intervention Names

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Near Infrared Autofluorescence (NIRAF) NIRAF detection modality PTeye

Eligibility Criteria

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Inclusion Criteria

* All adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
* All adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria

* Children and minors
* Pregnant women
* Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
* Patients with secondary or tertiary hyperparathyroidism

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No