A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- refused medical therapy
- had at least 3 prior months documented failed medical therapy; or
- ...
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- refused medical therapy
- had at least 3 prior months documented failed medical therapy; or
- had a contraindication to medical therapy; or
- Female subject from age 35 to 50 years
- Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
- Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
- Not pregnant and no desire to conceive at any time
- Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
- Subject who is literate or demonstrates an understanding on how to use menstrual diaries
- Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
Exclusion Criteria
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use
- Currently on anticoagulants
- ...
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use
- Currently on anticoagulants
- Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
- Active pelvic inflammatory disease
- Presence of bacteremia, sepsis, or other active systemic infection
- Pedunculated or submucosal myomas distorting the uterine cavity
- Pregnancy or subject with a desire to conceive
- Untreated/unevaluated cervical dysplasia
- Previous endometrial ablation procedure
- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Polyps likely to be the cause of the subject's menorrhagia
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
- Known/suspected gynecological malignancy within the past 5 years
- Presence of an intrauterine device (IUD)
- Complex endometrial hyperplasia as confirmed by histology
- Known/suspected abdominal/pelvic cancer
- Intramural or subserosal myomas that distort the uterine cavity
- Presence of active endometritis
- Active sexually transmitted disease (STD)
- Septate or bicornuate uterus or other congenital malformation of the uterine cavity
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- Known clotting defects or bleeding disorders
Summary
- Conditions
- Menorrhagia Due to Benign Causes
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 50 years
- Gender
- Only females
Inclusion Criteria
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- refused medical therapy
- had at least 3 prior months documented failed medical therapy; or
- ...
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- refused medical therapy
- had at least 3 prior months documented failed medical therapy; or
- had a contraindication to medical therapy; or
- Female subject from age 35 to 50 years
- Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
- Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
- Not pregnant and no desire to conceive at any time
- Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
- Subject who is literate or demonstrates an understanding on how to use menstrual diaries
- Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
Exclusion Criteria
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use
- Currently on anticoagulants
- ...
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use
- Currently on anticoagulants
- Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
- Active pelvic inflammatory disease
- Presence of bacteremia, sepsis, or other active systemic infection
- Pedunculated or submucosal myomas distorting the uterine cavity
- Pregnancy or subject with a desire to conceive
- Untreated/unevaluated cervical dysplasia
- Previous endometrial ablation procedure
- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Polyps likely to be the cause of the subject's menorrhagia
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
- Known/suspected gynecological malignancy within the past 5 years
- Presence of an intrauterine device (IUD)
- Complex endometrial hyperplasia as confirmed by histology
- Known/suspected abdominal/pelvic cancer
- Intramural or subserosal myomas that distort the uterine cavity
- Presence of active endometritis
- Active sexually transmitted disease (STD)
- Septate or bicornuate uterus or other congenital malformation of the uterine cavity
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- Known clotting defects or bleeding disorders
Tracking Information
- NCT #
- NCT02035332
- Collaborators
- Not Provided
- Investigators
- Not Provided
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