A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding (CLARITY)

Channel Medsystems

Status

Completed

Conditions

Menorrhagia

Treatments

Device: Cerene(R) Cryotherapy Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02842736

CIP-0101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.

Enrollment

242 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Refractory heavy menstrual bleeding with no definable organic cause
Female subject age 25 to 50 years, inclusive
Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm
Sufficient myometrial thickness
Documented excessive menstrual blood loss within 3 months of informed consent
Premenopausal confirmed by follicle stimulating hormone (FSH) measurement
Agrees to use a reliable form of contraception following ablation treatment
Provides written informed consent using a form that has been approved by the reviewing ethics committee
Agrees to follow-up exams and data collection requirements
Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram
Has predictable, cyclic menstrual cycles

Exclusion criteria

Pregnant or has a desire to conceive
Endometrial hyperplasia as confirmed by histology
Active endometritis
Active pelvic inflammatory disease
Active sexually transmitted disease (STD)
Presence of bacteremia, sepsis, or other active systemic infection
Active infection of the genitals, vagina, cervix, or uterus
Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
Known clotting defects or bleeding disorders
Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards.
Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section).
Previous low transverse cesarean section where the myometrial wall thickness is insufficient
Previous endometrial ablation procedure
Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment
Presence of an implantable contraceptive device
Currently on medications that could thin the myometrial muscle
Currently on anticoagulants
Abnormal or obstructed cavity
Currently using an intrauterine device (IUD) and unwilling to remove the IUD
Post-partum ≤ 6-months
Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements