Menorrhagia
Conditions
Keywords
endometrial ablation
Brief summary
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.
Detailed description
Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage typically provides relief for only a few menstrual cycles. Traditionally hysterectomy has been the definitive treatment for menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom childbearing is complete. Subjects who are randomized to the control group will receive hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be treated with the Aurora Endometrial Ablation System.
Interventions
DEVICEAurora Endometrial Ablation
Endometrial Ablation using the Aurora Endometrial Ablation system
DEVICERollerball Ablation/Resection
Hysteroscopic rollerball resection/ablation
Sponsors
Minerva Surgical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Refractory menorrhagia with no definable organic cause * Female subject from (and including) age 25 to 50 years * Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm * A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR, * A minimum menstrual blood loss of ≥ 160 ml for one baseline cycle for women who either * had at least 3 prior months documented failed medical therapy; or * had a contraindication to medical therapy * Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L * Not pregnant and no desire to conceive at any time * Subject agrees to use a reliable form of contraception up to the 12-month follow-up visit. If a hormonal birth control method is used for contraception, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through the initial 12-month follow-up * Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC * Subject agrees to follow-up exams and data collection requirements * Subject who is literate or demonstrates an understanding on how to collect menstrual blood loss products for the alkaline hematin method of analysis
Exclusion criteria
* Pregnancy or subject with a desire to conceive * Endometrial hyperplasia as confirmed by histology * Presence of active endometritis * Active pelvic inflammatory disease * Active sexually transmitted disease (STD) * Presence of bacteremia, sepsis, or other active systemic infection * Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure * Known/suspected abdominal pelvic or gynecological malignancy within the past 5 years * Known clotting defects or bleeding disorders * Untreated/unevaluated cervical dysplasia, except CIN I * Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section) * Previous endometrial ablation procedure * Presence of an implantable (intrauterine) contraceptive device (e.g. Essure™ or Adiana™) * Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma) * Currently on anticoagulants * Abnormal or obstructed cavity as confirmed by hysteroscopy, SIS or vaginal ultrasound * Presence of an intrauterine device (IUD) which the Subject is unwilling to have removed at the time of the operative visit * Subject currently on hormonal birth control therapy (including the Mirena device) for \<3 months prior to enrollment * Subject who is unwilling to use birth control post-ablation whether non-hormonal birth control or the same hormonal birth control therapy as before the procedure * Subject who is within 6-weeks post partum * Any subject who is currently participating or considers future participation in a research study of an investigational drug or device during the course of this investigational study * Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months | 12 months | Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | < 1 hour | Procedure time is defined as the time from device insertion to time of device removal. |
Countries
Canada, Mexico, United States
Participant flow
Recruitment details
Subjects were enrolled in the clinical trial at 13 Investigational Sites in the U.S., Canada, and Mexico between March 2012 until November 2013.
Pre-assignment details
A total of 153 subjects were enrolled and randomized 2:1 to the Minerva (Aurora) Test Group (n=102) or the Rollerball Control Group (n=51). As part of the randomization process, subjects were stratified by age, though there was no attempt to enroll an equal number into the \< 40 and \> 40 age groups. All 153 subjects were successfully treated.
Participants by arm
| Arm | Count |
|---|---|
| Aurora Endometrial Ablation Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system | 102 |
| Hysteroscopic Rollerball Resection/Ablation Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation | 51 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 7 |
Baseline characteristics
| Characteristic | Aurora Endometrial Ablation | Hysteroscopic Rollerball Resection/Ablation | Total |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 4.2 | 42.5 years STANDARD_DEVIATION 4.7 | 42.5 years STANDARD_DEVIATION 4.4 |
| Alkaline Hematin Value at Baseline | 310.2 Menstrual Blood Loss (ml) STANDARD_DEVIATION 169 | 301.8 Menstrual Blood Loss (ml) STANDARD_DEVIATION 176.1 | 307.4 Menstrual Blood Loss (ml) STANDARD_DEVIATION 170.9 |
| Region of Enrollment Canada | 54 participants | 26 participants | 80 participants |
| Region of Enrollment Mexico | 28 participants | 13 participants | 41 participants |
| Region of Enrollment United States | 20 participants | 12 participants | 32 participants |
| Sex: Female, Male Female | 102 Participants | 51 Participants | 153 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 102 | 10 / 51 |
| serious Total, serious adverse events | 5 / 102 | 3 / 51 |
Outcome results
Primary
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months
Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.
Time frame: 12 months
Population: All Randomized subjects in whom treatment was attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aurora Endometrial Ablation | Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months | 95 participants |
| Hysteroscopic Rollerball Resection/Ablation | Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months | 41 participants |
Secondary
Procedure Time
Procedure time is defined as the time from device insertion to time of device removal.
Time frame: < 1 hour
Population: Subjects completing treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aurora Endometrial Ablation | Procedure Time | 3.1 Minutes | Standard Deviation 0.5 |
| Hysteroscopic Rollerball Resection/Ablation | Procedure Time | 17.2 Minutes | Standard Deviation 6.7 |
Post Hoc
Subjects With Amenorrhea at 12 Months
Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding
Time frame: 12 Months
Population: Randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aurora Endometrial Ablation | Subjects With Amenorrhea at 12 Months | 73 participants |
| Hysteroscopic Rollerball Resection/Ablation | Subjects With Amenorrhea at 12 Months | 25 participants |