Rapid Testing Kit for Hyperparathyroidism

(Parakeet Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurovision Medical Products Inc

Disqualifiers: Unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lee J Rea, Dr

Principal Investigator

Neurovision Medical Product, Inc

Eligibility Criteria

This trial is for individuals with hyperparathyroidism or parathyroid adenomas who are undergoing surgery. Participants must have a confirmed diagnosis and be scheduled for surgical treatment. Details on specific inclusion and exclusion criteria are not provided, but typically these would outline health conditions or medications that might interfere with the study.

Inclusion Criteria

I am 18 or older and 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo parathyroidectomy and testing with the Parakeet Rapid Parathyroid Testing Kit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery and testing

4 weeks

Treatment Details

Interventions

• Parakeet Rapid Parathyroid Testing Kit

Trial Overview The Parakeet Rapid Parathyroid Testing Kit is being tested in this trial. It's designed to quickly detect PTH levels in tissue samples taken during surgery, and its results will be compared to traditional pathology to check accuracy.

Participant Groups

Group I: Parathyroidectomy Experimental Treatment 1 Intervention

Patients undergoing parathyroidectomy for Hyperparathyroidism

Who Is Running the Clinical Trial?

Neurovision Medical Products Inc

Lead Sponsor

Trials

1

Recruited

60+