STP.168 Clinical Study Protocol Parakeet

The Parakeet is a lateral flow cassette designed to aid in the detection of parathyroid gland by identifying tissue with parathyroid hormone levels > 60 pg./ml in a fine needle aspirate specimen. The FNA specimen of the target tissue is combined with running fluid and deposited into the sample well of a lateral flow cassette. Lateral flow occurs and the Test Line begins to darken within minutes if PTH is present in quantities > 60 pg./ml. At 5 minutes, a full visualization of the TL is done. A negative test (< 60 pg./ml of PTH in the sample) shows darkening of the Control Line only. Absence of Control Line development indicates a defective test kit.

INTENDED USE

The Parakeet Rapid Parathyroid Testing Kit is an immunoassay lateral flow cassette intended to detect qualitative differences in extracellular concentration of parathyroid hormone in excised samples suspected of being parathyroid glands as an adjunct to current clinical methods, including histopathology, to locate the parathyroid glands.

INDICATIONS FOR USE

The Parakeet Rapid Parathyroid Testing Kit is indicated for use in adult patients where location of the parathyroid glands is medically necessary, such as in patients undergoing parathyroidectomy for Hyperparathyroidism.

• Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample. (Device): The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample. The Parakeet is a point of care test completely controlled by the surgeon and operating team. It uses the scientific principle of "Lateral Flow" of antibody-antigen-conjugate complexes being arrested in a "Test Line".

Primary outcomes

• The participant's IVD PTH concentration is < 57 pg/ml and the pathology report will be negative for parathyroid gland. The participant's IVD PTH concentration is > 57 pg/ml and the pathology report will be positive for parathyroid gland. [5 minutes]: PT ID (visual): Visual Reading for FNA only; Positive (indicates a PTG), Negative (non-PTG). Qualitative variable, if the sample demonstrates a Test Line visual development, it is "Positive." If the Test Line does not demonstrate visual development this indicates less than the threshold of 60 pg./ml of PTH and it is considered negative (non-PTG) (Figure 5). The visual reading is by the tester and the surgeon is not notified. A faint or equivocal Test Line reading should be evaluated by the tester and repeated or other measures taken

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Men and women

≥18 years of age Scheduled for Parathyroid surgery

Exclusion Criteria:

Unable or unwilling to provide informed consent Subject has any condition that in the opinion of the investigator should preclude participation in the study

• Barczynski M, Branstrom R, Dionigi G, Mihai R. Sporadic multiple parathyroid gland disease--a consensus report of the European Society of Endocrine Surgeons (ESES). Langenbecks Arch Surg. 2015 Dec;400(8):887-905. doi: 10.1007/s00423-015-1348-1. Epub 2015 Nov 5. PMID 26542689
• Obolonczyk L, Karwacka I, Wisniewski P, Sworczak K, Oseka T. The Current Role of Parathyroid Fine-Needle Biopsy (P-FNAB) with iPTH-Washout Concentration (iPTH-WC) in Primary Hyperparathyroidism: A Single Center Experience and Literature Review. Biomedicines. 2022 Jan 6;10(1):123. doi: 10.3390/biomedicines10010123. PMID 35052802

• Lee J Rea, Dr, Study director, Neurovision Medical Product, Inc