Clinical trial NCT01979861: Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Menorrhagia
Keywords: Endometrial ablation with vapor
Lead sponsor: Aegea Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 230
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Detailed description: This is a single-arm, multi-center study with three years of follow-up.

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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Effectiveness Endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: New Britain
country: United States
facility: Center for Fertility and Women's Health
state: Connecticut
city: Orlando
country: United States
facility: Clinical Associates of Orlando, LLC
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark WomenCares Specialists
state: Idaho
city: Naperville
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: Newburgh
country: United States
facility: Basinksi, LLC
state: Indiana
city: Edina
country: United States
facility: Minnesota Gynecology & Surgery
state: Minnesota
city: St. Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center/OB-GYN
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints
state: Texas
city: Hamilton
country: Canada
facility: Department of Obstetrics and Gynecology
state: Ontario
city: Monterrey
country: Mexico
facility: Hospital Universitario de la Universidad Autonoma de Nuevo Leon
state: N.l.
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijissel
Study officials:
affiliation: Montefiore Medical Center
name: Mark Levie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.