Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06232720
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
Sponsor:
QART Medical
Organization:
Study Overview
Official Title:
Q300 User Site Testing Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
Detailed Description:
Testing the Usability of the Q300™ device.
Specific objectives of this evaluation are as follows:
* Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.
* Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.
* Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.
* Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.
* Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.
* Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.
* Evaluate effect of using the Q300 on the clinical outcome
Specific objectives of this evaluation are as follows:
* Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.
* Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.
* Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.
* Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.
* Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.
* Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.
* Evaluate effect of using the Q300 on the clinical outcome
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: