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

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.

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Device: Cerene(R) Cryotherapy Device

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7G9
      • Allan Centre
  • Quebec
    • Lasalle, Quebec, Canada, H8P 1C1
      • LaSalle Hospital
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 66460
      • Hospital Universitario de la Universidad Autonoma de Nuevo Leon
• United States
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • WomanCare PC
    • Naperville, Illinois, United States, 60540
      • The Advance Gynecologic Surgery Institute
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
    • Newburgh, Indiana, United States, 47630
      • Basinski LLC
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Women's Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Seven Hills Women's Health
    • Mason, Ohio, United States, 45040
      • Amy Brenner MD and Associates, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endometrial Cryoablation	Device: Cerene(R) Cryotherapy Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events		12 months
Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75	Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysmennorhea	Subjects were queried regarding if they suffer from dysmenorrhea (painful cramping associated with menstruation). The subject was asked to rate their level of dysmenorrhea on a scale from 0 to 5, with 0 indicating no symptoms and 5 indicating very severe symptoms. A score of 0 was considered better than a score of 5.	12 Months
Amenorrhea	Pictorial blood loss assessment (PBLAC) score = 0 Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.	12 Months
Investigator Evaluation of the Uterine Cavity		12 Months
Investigator Assessment of Cavity Findings	Questions to the investigator	12 Months
Anesthesia and Pain Medications at Treatment		Day of Treatment
Subject Rating of Pain During Treatment and Day One Post-Treatment	Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.	Day of Treatment and Day One Post-Treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects' Report of Their Last Menstrual Period	Subjects were asked to describe their last menstrual period	36 months
Menstrual Impact Questionnaire	Subjects' Report of Activity Limitations	36 months
Premenstrual Symptoms Impact Survey	Subjects' Report of Pre-Menstrual Symptoms (PMS)	36 months
Subject Satisfaction	Subject's level of satisfaction with the results of her Cerene treatment	36 Months
Subject Recommendation	Subjects' reported level of recommendation to a friend/family	36 months
Procedure Time	Device insertion to device removal	Day of Treatment
Return to Normal Daily Activities		Two-Weeks

Collaborators and Investigators

• Sponsor: Channel Medsystems

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: endometrial ablation; heavy menstrual bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: CIP-0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes