Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-18
2025-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Parathyroidectomy
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.
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".
Interventions
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Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample.
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".
Eligibility Criteria
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Inclusion Criteria
≥18 years of age Scheduled for Parathyroid surgery
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Neurovision Medical Products Inc
INDUSTRY
Responsible Party
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Christine Vergely
Director of Regulatory Affairs
Principal Investigators
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Lee J Rea, Dr
Role: STUDY_DIRECTOR
Neurovision Medical Product, Inc
Locations
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Ventura County Medical center Santa Paula
Ventura, California, United States
Countries
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References
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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.
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.
Other Identifiers
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STP.168
Identifier Type: -
Identifier Source: org_study_id
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