Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

Pregnancy or subject with a desire to conceive
Complex endometrial hyperplasia as confirmed by histology
Currently on anticoagulants
...
Pregnancy or subject with a desire to conceive
Complex endometrial hyperplasia as confirmed by histology
Currently on anticoagulants
Presence of bacteremia, sepsis, or other active systemic infection
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
Presence of an intrauterine device (IUD)
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
Pedunculated or submucosal myomas distorting the uterine cavity
Presence of active endometritis
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
Untreated/unevaluated cervical dysplasia
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Previous endometrial ablation procedure
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Polyps likely to be the cause of the subject's menorrhagia
Known/suspected gynecological malignancy within the past 5 years
Known/suspected abdominal/pelvic cancer
Active sexually transmitted disease (STD)
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Active pelvic inflammatory disease
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
Intramural or subserosal myomas that distort the uterine cavity

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

Exclusion Criteria

Pregnancy or subject with a desire to conceive
Complex endometrial hyperplasia as confirmed by histology
Currently on anticoagulants
...
Pregnancy or subject with a desire to conceive
Complex endometrial hyperplasia as confirmed by histology
Currently on anticoagulants
Presence of bacteremia, sepsis, or other active systemic infection
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
Presence of an intrauterine device (IUD)
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
Pedunculated or submucosal myomas distorting the uterine cavity
Presence of active endometritis
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
Untreated/unevaluated cervical dysplasia
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Previous endometrial ablation procedure
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Polyps likely to be the cause of the subject's menorrhagia
Known/suspected gynecological malignancy within the past 5 years
Known/suspected abdominal/pelvic cancer
Active sexually transmitted disease (STD)
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Active pelvic inflammatory disease
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
Intramural or subserosal myomas that distort the uterine cavity

Tracking Information

NCT #
NCT02035332
Collaborators
Not Provided
Investigators
Not Provided
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