Clinical trial NCT02842736: A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: heavy menstrual bleeding
endometrial ablation
Lead sponsor: Channel Medsystems
Sponsor class: INDUSTRY
First posted: 2016-07-25
Enrollment: 242
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
timeFrame: 12 months
measure: Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
timeFrame: 12 months
Secondary outcomes:
measure: Dysmennorhea
timeFrame: 12 Months
measure: Amenorrhea
timeFrame: 12 Months
measure: Investigator Evaluation of the Uterine Cavity
timeFrame: 12 Months
measure: Investigator Assessment of Cavity Findings
timeFrame: 12 Months
measure: Anesthesia and Pain Medications at Treatment
timeFrame: Day of Treatment
measure: Subject Rating of Pain During Treatment and Day One Post-Treatment
timeFrame: Day of Treatment and Day One Post-Treatment
Other outcomes:
measure: Subjects' Report of Their Last Menstrual Period
timeFrame: 36 months
measure: Menstrual Impact Questionnaire
timeFrame: 36 months
measure: Premenstrual Symptoms Impact Survey
timeFrame: 36 months
measure: Subject Satisfaction
timeFrame: 36 Months
measure: Subject Recommendation
timeFrame: 36 months
measure: Procedure Time
timeFrame: Day of Treatment
measure: Return to Normal Daily Activities
timeFrame: Two-Weeks
Locations:
city: Arlington Heights
country: United States
facility: WomanCare PC
state: Illinois
city: Naperville
country: United States
facility: The Advance Gynecologic Surgery Institute
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Newburgh
country: United States
facility: Basinski LLC
state: Indiana
city: Asheville
country: United States
facility: Asheville Women's Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Seven Hills Women's Health
state: Ohio
city: Mason
country: United States
facility: Amy Brenner MD and Associates, LLC
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Allan Centre
state: Alberta
city: Lasalle
country: Canada
facility: LaSalle Hospital
state: Quebec
city: Monterrey
country: Mexico
facility: Hospital Universitario de la Universidad Autónoma de Nuevo Leon
state: Nuevo Leon
Study officials:
References:
citation: Curlin HL, Anderson TL. Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study. Int J Womens Health. 2022 Aug 10;14:1083-1092. doi: 10.2147/IJWH.S371044. eCollection 2022.
citation: Curlin H, Cholkeri-Singh A, Leal JGG, Anderson T. Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device. J Minim Invasive Gynecol. 2022 Mar;29(3):440-447. doi: 10.1016/j.jmig.2021.11.016. Epub 2021 Nov 25.
citation: Curlin HL, Cintron LC, Anderson TL. A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. J Minim Invasive Gynecol. 2021 Apr;28(4):899-908. doi: 10.1016/j.jmig.2020.08.013. Epub 2020 Aug 22.