Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394752
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-25
Brief Title:
UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus
Sponsor:
Center for Reproductive Health Gynecology
Organization:
Center for Reproductive Health Gynecology
Study Overview
Official Title:
UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is a prospective single center multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device VSI device vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus
Detailed Description:
This is a prospective single center multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device VSI device vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus
Patients who are enrolled in the study will have a 1 Hydrosonography and 2 Visual Saline Infusion procedure performed
The Visual Saline Infusion Device is a 27mm steerable tip catheter with a camera and illumination at the distal end The device is intended to evaluate the intrauterine space in an office based outpatient setting using minimal volume of fluid 3-5ccs
This study will recruit up to 100 women from a fertility center in Los Angeles
Patients who are enrolled in the study will have a 1 Hydrosonography and 2 Visual Saline Infusion procedure performed
The Visual Saline Infusion Device is a 27mm steerable tip catheter with a camera and illumination at the distal end The device is intended to evaluate the intrauterine space in an office based outpatient setting using minimal volume of fluid 3-5ccs
This study will recruit up to 100 women from a fertility center in Los Angeles
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?:
True
Is an FDA AA801 Violation?:
None