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Completed

NCT Number: NCT05022641

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

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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Key information

Conditions

Parathyroid Adenoma Calcium Metabolism Disorders Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Primary Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Parathyroid Cancer Parathyroid Diseases Parathyroid Neoplasms Primary Hyperparathyroidism Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTeye

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

Other

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

Primary outcomes

  1. Average Number of Parathyroid Glands Identified

    Time frame: Measured within the procedure, generally not more than 2 hours

    Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.

Secondary outcomes

  1. Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery

    Time frame: 5-14 days after surgery

    Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.

  2. Appropriate Intraoperative Parathyroid Hormone Drop

    Time frame: baseline to 10 minutes

    >50% drop from baseline at 10 minutes post-resection

  3. Duration of Surgery

    Time frame: Measured within the procedure, generally not more than 2 hours

    Surgery duration in minutes

  4. Number of Nights Spent in the Hospital After Parathyroidectomy

    Time frame: 0-72 hours after PTx procedure.

    Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

  5. Number of Frozen Sections

    Time frame: Immediate

    Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • Vanderbilt University

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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