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

Completed · Not applicable

Conditions studied: Menorrhagia

In brief

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.

Key facts

Study ID

NCT02842736

Run by

Channel Medsystems

People needed

242

Starts

2016-04-01

Expected to finish

2020-05-01

Last updated by the study team

2021-01-05

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• WomanCare PC — Arlington Heights, Illinois, United States
• The Advance Gynecologic Surgery Institute — Naperville, Illinois, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Basinski LLC — Newburgh, Indiana, United States
• Asheville Women's Medical Center — Asheville, North Carolina, United States
• Seven Hills Women's Health — Cincinnati, Ohio, United States
• Amy Brenner MD and Associates, LLC — Mason, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Premier Clinical Research — Spokane, Washington, United States
• Allan Centre — Calgary, Alberta, Canada
• LaSalle Hospital — LaSalle, Quebec, Canada
• Hospital Universitario de la Universidad Autónoma de Nuevo Leon — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

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