Clinical trial NCT06499142: STP.168 Clinical Study Protocol Parakeet
Official title: STP.168 Clinical Study Protocol Parakeet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parathyroid; Anomaly
Parathyroid Dysfunction
Hyperparathyroidism
Parathyroid Gland Adenoma
Keywords: Immunoassay Lateral Flow, Parathyroid gland, PTH, FNA
Parathyroid gland,
PTH,
FNA
Lead sponsor: Neurovision Medical Products Inc
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: STUDY PURPOSE

The purpose of this study is to demonstrate the performance of the Parakeet Rapid Parathyroid Testing Kit by comparing Parakeet results with histopathologic Diagnosis.

STUDY OBJECTIVES

To demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Parakeet Rapid Parathyroid Testing kit test results in FNA from excised tissue during parathyroid surgery with Pathologic Diagnosis.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura County Medical center Santa Paula
state: California
Study officials:
affiliation: Neurovision Medical Product, Inc
name: Lee J Rea, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.