Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499142
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-19
Brief Title:
STP168 Clinical Study Protocol Parakeet
Sponsor:
Neurovision Medical Products Inc
Organization:
Neurovision Medical Products Inc
Study Overview
Official Title:
STP168 Clinical Study Protocol Parakeet
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Parakeet
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
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
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 pgml 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 pgml At 5 minutes a full visualization of the TL is done A negative test 60 pgml 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None