Brief Summary
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
Brief Title
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
Detailed Description
This is a single-arm, multi-center study with three years of follow-up.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Menorrhagia
Eligibility Criteria
Inclusion Criteria:
* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Exclusion Criteria:
* Pregnant
* Desires future childbearing
* Presence of an IUD
* Previous endometrial ablation procedure
* Evidence of STI
* Evidence of PID
* Active infection of genitals, vagina, cervix, uterus or urinary tract
* Active endometritis
* Active bacteremia, sepsis or other active systemic infection
* Gynecologic malignancy
* Endometrial hyperplasia
* Known clotting defects or bleeding disorders
* On anticoagulant therapy
* Hemoglobin \<8gm/dl
* Prior uterine surgery
* Currently on medication that could thin myometrial muscle
* Severe dysmenorrhea, secondary to adenomyosis
* Abnormal uterine cavity
* Hydrosalpinx
* Uterine length \<6cm or \>12cm
* Currently in other clinical trial
* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Exclusion Criteria:
* Pregnant
* Desires future childbearing
* Presence of an IUD
* Previous endometrial ablation procedure
* Evidence of STI
* Evidence of PID
* Active infection of genitals, vagina, cervix, uterus or urinary tract
* Active endometritis
* Active bacteremia, sepsis or other active systemic infection
* Gynecologic malignancy
* Endometrial hyperplasia
* Known clotting defects or bleeding disorders
* On anticoagulant therapy
* Hemoglobin \<8gm/dl
* Prior uterine surgery
* Currently on medication that could thin myometrial muscle
* Severe dysmenorrhea, secondary to adenomyosis
* Abnormal uterine cavity
* Hydrosalpinx
* Uterine length \<6cm or \>12cm
* Currently in other clinical trial
Inclusion Criteria
Inclusion Criteria:
* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
* Female subject from (and including) age 30 to 50 years
* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
* Predictable cyclic menstrual cycles over past 6 months
* Excessive uterine bleeding
* Premenopausal at enrollment
* Normal PAP
* Normal endometrial biopsy
* Willing to use reliable contraception
* Not currently taking hormonal medication
* Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Gender
Female
Gender Based
false
Keywords
Endometrial ablation with vapor
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
30 Years
NCT Id
NCT01979861
Org Class
Industry
Org Full Name
Aegea Medical, Inc.
Org Study Id
SE-3000
Overall Status
Unknown status
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
Primary Outcomes
Outcome Description
Reduction of menstrual blood loss
Outcome Measure
Primary Effectiveness Endpoint
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
Quality of Life
Outcome Time Frame
12 months
Outcome Measure
Secondary Effectiveness Endpoint
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
30
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Levie
Investigator Email
malevie@montefiore.org
Investigator Phone
Categories Mesh Debug
Gynecologic Cancers --- UTERINE DISEASES
Blood Disorders --- HEMORRHAGE
MeSH Terms
MENORRHAGIA
UTERINE HEMORRHAGE
UTERINE DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
HEMORRHAGE
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
MENSTRUATION DISTURBANCES