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

NCT ID: NCT02842736

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-05-31

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.

Conditions

Menorrhagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endometrial Cryoablation

Group Type: EXPERIMENTAL

Cerene(R) Cryotherapy Device

Intervention Type: DEVICE

Interventions

Cerene(R) Cryotherapy Device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Channel Medsystems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Canada; Mexico

References

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.

Reference Type: DERIVED

PMID: 35983177 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34839060 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32835865 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP-0101

Identifier Type: -

Identifier Source: org_study_id