Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System

Completed · Phase 4

Conditions studied: Menorrhagia

In brief

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.

Key facts

Study ID

NCT00094536

Run by

CooperSurgical Inc.

People needed

82

Starts

2004-04-01

Expected to finish

2009-06-01

Last updated by the study team

2017-03-03

Who can join

Age: 30 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kelly Roy, M.D., P.C. — Phoenix, Arizona, United States
• Institute for Women's Health & Body — Wellington, Florida, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Valley OB/GYN — Saginaw, Michigan, United States
• Center for Endometrial Ablation — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Jose Manjon, M.D. (Private practice) — Camp Hill, Pennsylvania, United States

Full record on ClinicalTrials.gov

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