At a glance
ClinicalIndex Comparison Record- ✓Pre-menopausal women aged 30 or older
- ✓Completed childbearing
- ✓Heavy or prolonged menstrual bleeding
- ✓Willing and able to complete all follow-up exams
- ✕Known or suspected endometrial cancer or pre-malignant endometrial change
- ✕Untreated cervical dysplasia
- ✕Hereditary uterine cavity malformations that would prevent probe insertion or placement
- ✕Uterine fibroids ≥3 cm in diameter
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia
In Brief
A Phase 4 clinical trial evaluating Extended treatment regimen using Her Option Cryotherapy for Menorrhagia. Completed, enrolled 82 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.