Menorrhagia Due to Benign Causes
Conditions
Keywords
Menorrhagia, Excessive uterine bleeding, Endometrial Ablation
Brief summary
This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an objective standard. Safety will be evaluated by determining the number and percentage of subjects who experience one or more of serious adverse events.
Interventions
Ablation of the endometrial lining of the uterus using the Aurora System
Sponsors
Minerva Surgical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Refractory menorrhagia with no definable organic cause 2. Female subject from age 25 to 50 years 3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus) 4. One of the following criteria: A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB). B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a minimum PBLAC score of ≥150 for 1 month prior to study enrollment. 5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml 6. Not pregnant and no desire to be pregnant in the future 7. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study 8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC 9. Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries for PBLAC analysis. 10. Subject who is literate or demonstrates an understanding on how to use menstrual diaries.
Exclusion criteria
1. Pregnancy or subject with a desire to conceive 2. Endometrial hyperplasia as confirmed by histology 3. Presence of active endometritis 4. Active pelvic inflammatory disease 5. Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment. 6. Presence of bacteremia, sepsis, or other active systemic infection 7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure 8. Known/suspected gynecological malignancy within the past 5 years 9. Known clotting defects or bleeding disorders 10. Untreated/unevaluated cervical dysplasia (except CIN I) 11. Known/suspected abdominal/pelvic cancer 12. Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section) 13. Previous endometrial ablation procedure 14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma) 15. Currently on anticoagulants 16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically: 1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity 2. Pedunculated or submucosal myomas distorting the uterine cavity 3. Polyps likely to be the cause of the subject's menorrhagia 4. Intramural or subserosal myomas that distort the uterine cavity 17. Presence of an intrauterine device (IUD) which the patient is unwilling to have removed at the time of the operative visit 18. Presence of an implantable contraceptive device (e.g. Essure or Adiana). 19. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device). 20. Subject who is within 6-weeks post partum. 21. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject 22. Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Menstrual Blood Loss to Normal Levels at 12 Months | 12 Months | Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \<=75. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | < 1 hour | Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal. |
Countries
Canada
Participant flow
Recruitment details
Subjects were enrolled in the clinical trial at 3 investigational sites in Canada from June 2011 until October 2011.
Pre-assignment details
63 subjects enrolled: 3 subjects excluded based on pre-procedure hysteroscopy screening and did not receive treatment. The remaining 60 subjects completed the study treatment. The protocol ITT population included all subjects in whom treatment was attempted (the experimental device was attempted to be placed).
Participants by arm
| Arm | Count |
|---|---|
| Aurora Treatment Arm Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Aurora Treatment Arm |
|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 5 |
| PBLAC Score (assessment of menstrual blood loss) | 503.0 units on a scale STANDARD_DEVIATION 412.3 |
| Region of Enrollment Canada | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \<=75.
Time frame: 12 Months
Population: Protocol Intent-to-treat populations (all subjects in whom the experimental device was attempted to be placed)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aurora Treatment Arm | Reduction in Menstrual Blood Loss to Normal Levels at 12 Months | 58 participants |
Secondary
Procedure Time
Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.
Time frame: < 1 hour
Population: Subjects completing treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aurora Treatment Arm | Procedure Time | 3.8 Minutes | Standard Deviation 1.3 |
Post Hoc
Subjects With Amenorrhea at 12 Months
Amenorrhea at 12 Months- Number of subjects experiencing no menstrual bleeding
Time frame: 12 Months
Population: Protocol Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aurora Treatment Arm | Subjects With Amenorrhea at 12 Months | 41 participants |