STP.168 Clinical Study Protocol Parakeet (Parakeet)

July 8, 2024 updated by: Christine Vergely, Neurovision Medical Products Inc

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Ventura County Medical center Santa Paula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parathyroidectomy
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.
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurovision Medical Products Inc

Investigators

  • Study Director: Lee J Rea, Dr, Neurovision Medical Product, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STP.168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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