An interventional study of Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample. in Parathyroid; Anomaly, Parathyroid Dysfunction and Hyperparathyroidism, sponsored by Neurovision Medical Products Inc. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Neurovision Medical Products Inc · Not applicable, Interventional, and Other
Among 46 studies in Hyperparathyroidism with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Hyperparathyroidism · United States.
Among the 46 studies in Hyperparathyroidism with a site in United States, this one is the 9th largest by planned enrollment of the 31 interventional ones, is one of 2 that started in 2023, is one of 11 with no phase, and was the 43rd registered.
110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.
This study's planned enrollment of 60 is above the median of 53 across 67 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →4 of the 46 studies in Hyperparathyroidism with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 9 Hyperparathyroidism studies recruiting now, 6 (67%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 2 started in 2023.
Median enrollment 30 across the 31 interventional studies, 80 across the 14 observational. Of the 34 that completed or were terminated, 18 (53%) have results posted.
10 of 46 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Neurovision Medical Products Inc as lead sponsor.
Neurovision Medical Products Inc has 1 study filed under Hyperparathyroidism — fewer than ten, so there is no comparison to draw.
1 of the studies in Hyperparathyroidism with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07103876University of FloridaParathyroidectomy and Mobility Study | 2027-03-01 |
Among the 46 studies in Hyperparathyroidism with a site in United States, from their registry updates:
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.
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.
110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.
This study's planned enrollment of 60 is above the median of 53 across 67 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →This is the only study on the registry with Neurovision Medical Products Inc as lead sponsor.
Compared within Hyperparathyroidism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men and women
≥18 years of age Scheduled for Parathyroid surgery
Exclusion Criteria:
Unable or unwilling to provide Subject has any condition that in the opinion of the investigator should preclude participation in the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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".
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
Time frame: 5 minutes
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.
Of 18 interventional studies with no phase under Hyperparathyroidism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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