A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- CooperSurgical Inc.
- Enrollment
- 82
- Locations
- 7
- Primary Endpoint
- Success (Reduction in Menstruation to Normal Levels)
Study Overview
Brief Summary
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be performed in a physicians office with minimal sedation.
Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu.
Since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. The results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.
Detailed Description
American Medical Systems, Inc. (AMS) hypothesized that the original treatment pattern used to support a previous FDA approval for the Her Option® Cryoablation Therapy System for Treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pre-menopausal adult women 30 years of age or older who have completed childbearing
- •Heavy or prolonged menstrual bleeding
- •Willing and able to complete all follow-up exams as required by protocol
Exclusion Criteria
- •Known or suspected endometrial cancer or pre-malignant change of the endometrium
- •Untreated cervical dysplasia
- •Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
- •Uterine myomas > or = to 3 cm in diameter
- •Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
- •History of classical (not low transverse incision) cesarean section
- •Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
- •Intrauterine device (IUD) in place
- •Other medical conditions could be exclusionary upon evaluation for study treatment
Arms & Interventions
Extended Treatment Regimen
Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
Intervention: Extended treatment regimen using Her Option Cryotherapy (Device)
Outcomes
Primary Outcomes
Success (Reduction in Menstruation to Normal Levels)
Time Frame: 1 Year
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
Secondary Outcomes
No secondary outcomes reported