Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
...
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
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)
Presence of active endometritis
Pedunculated or submucosal myomas distorting the uterine cavity
Known/suspected abdominal/pelvic cancer
Intramural or subserosal myomas that distort the uterine cavity
Known clotting defects or bleeding disorders
Polyps likely to be the cause of the subject's menorrhagia
Active pelvic inflammatory disease
Presence of bacteremia, sepsis, or other active systemic infection
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Previous endometrial ablation procedure
Currently on anticoagulants
Complex endometrial hyperplasia as confirmed by histology
Untreated/unevaluated cervical dysplasia
Active sexually transmitted disease (STD)
Pregnancy or subject with a desire to conceive
Septate or bicornuate uterus or other congenital malformation of 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

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

Exclusion Criteria

Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
...
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
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)
Presence of active endometritis
Pedunculated or submucosal myomas distorting the uterine cavity
Known/suspected abdominal/pelvic cancer
Intramural or subserosal myomas that distort the uterine cavity
Known clotting defects or bleeding disorders
Polyps likely to be the cause of the subject's menorrhagia
Active pelvic inflammatory disease
Presence of bacteremia, sepsis, or other active systemic infection
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Previous endometrial ablation procedure
Currently on anticoagulants
Complex endometrial hyperplasia as confirmed by histology
Untreated/unevaluated cervical dysplasia
Active sexually transmitted disease (STD)
Pregnancy or subject with a desire to conceive
Septate or bicornuate uterus or other congenital malformation of the uterine cavity

Tracking Information

NCT #
NCT02035332
Collaborators
Not Provided
Investigators
Not Provided
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