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Completed

NCT Number: NCT05022667

Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

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

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hypoparathyroidism Neoplasms Neoplasms by Site Parathyroid Diseases Thyroid Diseases

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

  • Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
  • Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

Exclusion criteria

  • Pregnant women
  • Patients with concurrent parathyroid and thyroid disease
  • Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
  • Patients undergoing thyroid lobectomy or partial thyroidectomy

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, as per device functionality requirements.

Primary outcomes

  1. The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient

    Time frame: Immediate (During total thyroidectomy procedure)

    Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

Secondary outcomes

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

    Time frame: 5-14 days after surgery

    Blood parathyroid hormone (PTH) levels at 5-14 days post-op

  2. Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery

    Time frame: Within 24-48 hours after surgery

    Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery

  3. Blood Calcium Levels 24-48 Hours After Surgery

    Time frame: Within 24-48 hours after surgery

    Blood calcium levels 24-48 hours after surgery

  4. Duration in Minutes of Surgery

    Time frame: Collected immediately following surgery

    Duration of surgery (minutes)

  5. Number of Frozen Section Analysis Performed.

    Time frame: Collected immediately following surgery

    Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.

  6. Number of Auto-transplanted Parathyroid Glands

    Time frame: Immediate. During total thyroidectomy procedure

    Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.

  7. Number of Nights Spent in the Hospital After Total Thyroidectomy

    Time frame: 0 - 4 nights after total thyroidectomy

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

  8. Number of Inadvertently Resected Parathyroid Glands

    Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)

    Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. Results reflect the participants who had an inadvertently resected parathyroid gland.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Vanderbilt University

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Aug 8, 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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