Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.

ABSTRACT:

Study objective

To examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene^® Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing.

Methods

The prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound ≤10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of ≥150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month

SUBMITTER: Curlin HL 

PROVIDER: S-EPMC9379116 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature