NIRAF Detection with PTeye for Thyroid Surgery

Recruiting in Palo Alto (17 mi)

Overseen byPaul Gauger

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if using a special light and device to see parathyroid glands during thyroid surgery is better than relying on the surgeon's eyes alone. It focuses on patients having their thyroid gland removed and aims to make the surgery safer by protecting the parathyroid glands. A new technology in thyroid surgery helps better locate and preserve parathyroid glands.

Research Team

Paul Gauger

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for patients with thyroid disease scheduled for total thyroidectomy, including those who've had prior neck surgery but still have an intact thyroid. It's not open to pregnant women, those with both parathyroid and thyroid diseases, or if only part of the thyroid is being removed.

Inclusion Criteria

I have thyroid disease and will have my entire thyroid removed.

I have ongoing thyroid issues and will have more thyroid surgery.

Exclusion Criteria

My enlarged parathyroid was found during my thyroid surgery.

I am having part of my thyroid removed.

I have both parathyroid and thyroid disease.

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Treatment Details

Interventions

PTeye (Procedure)

Trial OverviewThe study tests whether using a device called 'Parathyroid Eye (PTeye)' to detect near infrared autofluorescence (NIRAF) helps surgeons better identify parathyroid glands during complete removal of the thyroid gland compared to surgeon's detection alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: PTeyeExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.