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

University of Michigan

Status: Completed

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

Treatments: Device: PTeye

Study type: Interventional

Funder types: Other

Identifiers

NCT05022667

HUM00194322

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

PTeye

Experimental group

Description:

The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure.

Treatment:

Device: PTeye

Standard of Care

No Intervention group

Description:

The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.