STP.168 Clinical Study Protocol Parakeet

NCT06499142 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STP.168
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parathyroid; Anomaly; Parathyroid Dysfunction; Hyperparathyroidism; Parathyroid Gland Adenoma

Keywords

Immunoassay Lateral Flow, Parathyroid gland, PTH, FNA; Parathyroid gland,; PTH,; FNA

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  5 minutes

Study Arms (1)

Parathyroidectomy

EXPERIMENTAL

Patients undergoing parathyroidectomy for Hyperparathyroidism

Device: Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample.

Interventions

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".

Parathyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• ≥18 years of age Scheduled for Parathyroid surgery

You may not qualify if:

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

Sponsors & Collaborators

• Neurovision Medical Products Inc: lead

Study Sites (1)

Ventura County Medical center Santa Paula

Ventura, California, 93003, United States

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities; Parathyroid Diseases; Hyperparathyroidism; Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Lee J Rea, Dr

  Neurovision Medical Product, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regulatory Affairs

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 12, 2024
• Study Start: December 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)