Neoplasms

Gland and Hormone Related Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Hypoparathyroidism

Endocrine Gland Neoplasms

Endocrine System Diseases

Parathyroid Diseases

Hypocalcemia

All Drugs and Chemicals

Parathyroid Hormone

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.

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.

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.

PTeye

Anee Sophia Jackson

Hunter Underwood

Paul Gauger

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.

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

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

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

Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.

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

National Cancer Institute (NCI)

Vanderbilt University

University of Michigan

Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School

Adenoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Hypercalcemia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Primary Hyperparathyroidism

Parathyroid Carcinoma

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.

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

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.

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.

Only participants will be masked to the intervention

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

Intraoperative levels, (e.g. baseline, excision, 5 minutes).

Repeat surgeries are documented as binary (yes or no)

Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.

Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.

Time taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L.

Number of patients with repeat PTx procedure performed after the current procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy	NCT05022667	Thyroid Neoplas... Thyroid Disease... Hypoparathyroid... Endocrine Syste... Endocrine Gland... Neoplasms by Si... Neoplasms Head and Neck N... Parathyroid Dis...	PTeye	18 Years -	University of Michigan
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT05022641	Parathyroid Ade... Parathyroid Neo... Parathyroid Can... Hypercalcemia Primary Hyperpa...	PTeye	18 Years -	University of Michigan
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT05022641	Parathyroid Ade... Parathyroid Neo... Parathyroid Can... Hypercalcemia Primary Hyperpa...	PTeye	18 Years -	University of Michigan

Spots Global Cancer Trial Database for pteye

Every month we try and update this database with for pteye cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pteye

Every month we try and update this database with for pteye cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pteye cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.