Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01979861

Enrollment

230

Registered

2013-11-08

Start date

2014-02-28

Completion date

2018-06-30

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

Keywords

Endometrial ablation with vapor

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.

Interventions

DEVICEAEGEA Vapor System(TM)

vapor endometrial ablation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Effectiveness Endpoint	12 months	Reduction of menstrual blood loss

Secondary

Measure	Time frame	Description
Secondary Effectiveness Endpoint	12 months	Quality of Life

Countries

Canada, Mexico, Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026