Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634719
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding HMB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Use for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding HMB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicenter single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding HMB in women with a history of chronic ovulatory HMB
Detailed Description:
This is a prospective multicenter single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System HS for temporary control of heavy menstrual bleeding HMB in women with a history of chronic ovulatory HMB
Consenting subjects will be screened for eligibility and will have a baseline evaluation including medical and gynecological history and characterization of their menstrual cycle
Eligible subjects will be tentatively scheduled for Juveena HS treatment aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen MVJ menstrual bleeding scale to be started on day 1 of the index menstrual period On treatment day eligibility will be confirmed including confirmation of HMB and a negative urine pregnancy test and an MVJ score documented pre- and post-treatment Phone visits will be conducted post-treatment Days 1 14 and 56 Clinic visits will be conducted post-treatment on Day 7 and Day 28
Consenting subjects will be screened for eligibility and will have a baseline evaluation including medical and gynecological history and characterization of their menstrual cycle
Eligible subjects will be tentatively scheduled for Juveena HS treatment aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen MVJ menstrual bleeding scale to be started on day 1 of the index menstrual period On treatment day eligibility will be confirmed including confirmation of HMB and a negative urine pregnancy test and an MVJ score documented pre- and post-treatment Phone visits will be conducted post-treatment Days 1 14 and 56 Clinic visits will be conducted post-treatment on Day 7 and Day 28
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None