Evaluating Impact of 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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-05-31

Brief Summary

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This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

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Detailed Description

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Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Conditions

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Parathyroid Adenoma Parathyroid Neoplasms Parathyroid Cancer Hypercalcemia Primary Hyperparathyroidism

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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PTeye

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

PTeye

Intervention Type DEVICE

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.

Standard of Care

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Group Type OTHER

Standard of Care

Intervention Type OTHER

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Interventions

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PTeye

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.

Intervention Type DEVICE

Standard of Care

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary hyperparathyroidism who will be undergoing parathyroid surgery
* Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria

* Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
* 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