Menorrhagia Due to Benign Causes
Conditions
Keywords
Excessive Uterine Bleeding, Menorrhagia, Endometrial Ablation
Brief summary
The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.
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
35 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding) 2. Female subject from age 35 to 50 years 3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus) 4. A minimum PBLAC score of \>150 for 3 months prior to study enrollment; OR, A minimum PBLAC score \>150 for one month for women who either 1. had at least 3 prior months documented failed medical therapy; or 2. had a contraindication to medical therapy; or 3. refused medical therapy 5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml 6. Not pregnant and no desire to conceive at any time 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 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. Complex endometrial hyperplasia as confirmed by histology 3. Presence of active endometritis 4. Active pelvic inflammatory disease 5. Active sexually transmitted disease (STD) 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 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., transmural 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 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) 18. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation. 19. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject 20. Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
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. A score of 0 represents no bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Day of procedure | Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal. |
Countries
Hungary
Participant flow
Recruitment details
Subjects were enrolled in the clinical trial at 3 investigational sites in Hungary from May 2011 until October 2011.
Pre-assignment details
23 subjects enrolled: 2 subjects excluded based on pre-procedure hysteroscopy findings and did not receive treatment, in 1 subject treatment was attempted but procedure was aborted due to the width of the uterus, the remaining 20 subjects completed study treatment. The protocol ITT population included all subjects in whom treatment was attempted.
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 | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Procedure Aborted due to Uterine Width | 1 |
Baseline characteristics
| Characteristic | Aurora Treatment Arm |
|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 3.5 |
| PBLAC Score (assessment of menstrual blood loss) | 419.2 units on a scale STANDARD_DEVIATION 152.2 |
| Region of Enrollment Hungary | 23 participants |
| Sex: Female, Male Female | 23 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 | 13 / 21 |
| serious Total, serious adverse events | 1 / 21 |
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. A score of 0 represents no bleeding.
Time frame: 12 Months
Population: Protocol Intent-to-treat population (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 | 20 participants |
Secondary
Procedure Time
Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.
Time frame: Day of procedure
Population: Subjects completing treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aurora Treatment Arm | Procedure Time | 5.2 Minutes | Standard Deviation 2.1 |
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 | 11 participants |