Recruitment

Recruitment Status
Completed

Inclusion Criteria

Female subject from age 35 to 50 years
Not pregnant and no desire to conceive at any time
had at least 3 prior months documented failed medical therapy; or
...
Female subject from age 35 to 50 years
Not pregnant and no desire to conceive at any time
had at least 3 prior months documented failed medical therapy; or
Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
Subject who is literate or demonstrates an understanding on how to use menstrual diaries
Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
had a contraindication to medical therapy; or
refused medical therapy

Exclusion Criteria

Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Known clotting defects or bleeding disorders
...
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Known clotting defects or bleeding disorders
Known/suspected gynecological malignancy within the past 5 years
Untreated/unevaluated cervical dysplasia
Previous endometrial ablation procedure
Pedunculated or submucosal myomas distorting the uterine cavity
Active sexually transmitted disease (STD)
Complex endometrial hyperplasia as confirmed by histology
Pregnancy or subject with a desire to conceive
Known/suspected abdominal/pelvic cancer
Intramural or subserosal myomas that distort the uterine cavity
Active pelvic inflammatory disease
Polyps likely to be the cause of the subject's menorrhagia
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Currently on anticoagulants
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
Presence of bacteremia, sepsis, or other active systemic infection
Presence of active endometritis
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
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
Presence of an intrauterine device (IUD)

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

Female subject from age 35 to 50 years
Not pregnant and no desire to conceive at any time
had at least 3 prior months documented failed medical therapy; or
...
Female subject from age 35 to 50 years
Not pregnant and no desire to conceive at any time
had at least 3 prior months documented failed medical therapy; or
Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
Subject who is literate or demonstrates an understanding on how to use menstrual diaries
Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
had a contraindication to medical therapy; or
refused medical therapy

Exclusion Criteria

Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Known clotting defects or bleeding disorders
...
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Known clotting defects or bleeding disorders
Known/suspected gynecological malignancy within the past 5 years
Untreated/unevaluated cervical dysplasia
Previous endometrial ablation procedure
Pedunculated or submucosal myomas distorting the uterine cavity
Active sexually transmitted disease (STD)
Complex endometrial hyperplasia as confirmed by histology
Pregnancy or subject with a desire to conceive
Known/suspected abdominal/pelvic cancer
Intramural or subserosal myomas that distort the uterine cavity
Active pelvic inflammatory disease
Polyps likely to be the cause of the subject's menorrhagia
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Currently on anticoagulants
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
Presence of bacteremia, sepsis, or other active systemic infection
Presence of active endometritis
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
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
Presence of an intrauterine device (IUD)

Tracking Information

NCT #
NCT02035332
Collaborators
Not Provided
Investigators
Not Provided
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