Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02035332
Collaborators
Not Provided
Investigators
Not Provided
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