Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-04-20 @ 8:53 AM
Study NCT ID:
NCT02475395
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
Sponsor:
Sandstone Diagnostics
Organization:
Study Overview
Official Title:
A Clinical Study Evaluating Consumer Use of a New Device (TRAK) to Measure Sperm Concentration From Human Semen Samples, and Comparing TRAK Test Results With Laboratory Reference Method Testing
Status:
COMPLETED
Status Verified Date:
2017-09
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:
None
Brief Summary:
The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: