NCT02842736

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

July 21, 2016

Results QC Date

April 25, 2019

Last Update Submit

December 9, 2020

Conditions

Menorrhagia

Keywords

heavy menstrual bleedingendometrial ablation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Dysmennorhea

    12 Months

  • Amenorrhea

    12 Months

  • Investigator Evaluation of the Uterine Cavity

    12 Months

  • Investigator Assessment of Cavity Findings

    12 Months

  • Anesthesia and Pain Medications at Treatment

    Day of Treatment

  • +1 more secondary outcomes

Other Outcomes (7)

  • Subjects' Report of Their Last Menstrual Period

    36 months

  • Menstrual Impact Questionnaire

    36 months

  • Premenstrual Symptoms Impact Survey

    36 months

  • +4 more other outcomes

Study Arms (1)

Endometrial Cryoablation

EXPERIMENTAL
Device: Cerene(R) Cryotherapy Device

Interventions

Cerene(R) Cryotherapy DeviceDEVICE
Endometrial Cryoablation

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

WomanCare PC

Arlington Heights, Illinois, 60004, United States

Location

The Advance Gynecologic Surgery Institute

Naperville, Illinois, 60540, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Basinski LLC

Newburgh, Indiana, 47630, United States

Location

Asheville Women's Medical Center

Asheville, North Carolina, 28801, United States

Location

Seven Hills Women's Health

Cincinnati, Ohio, 45231, United States

Location

Amy Brenner MD and Associates, LLC

Mason, Ohio, 45040, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Allan Centre

Calgary, Alberta, T2J 7G9, Canada

Location

LaSalle Hospital

LaSalle, Quebec, H8P 1C1, Canada

Location

Hospital Universitario de la Universidad Autónoma de Nuevo Leon

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 35983177DERIVED

  • 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.

    PMID: 34839060DERIVED

  • 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.

    PMID: 32835865DERIVED

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Results Point of Contact

Title
Clinical and Regulatory Affairs
Organization
Channel Medsystems
clinreg@channelmedsystems.com
510-338-9301

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 25, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

May 1, 2020

Last Updated

January 5, 2021

Results First Posted

June 6, 2019

Record last verified: 2020-12

Locations

US(9)ME(1)CA(2)