MenorrhagiaCLARITYNCT02842736
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
A study testing Cerene(R) Cryotherapy Device in people with Menorrhagia, run by Channel Medsystems at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Cerene(R) Cryotherapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Apr 2016to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
WomanCare PC
Arlington Heights, Illinois, 60004
Asheville Women's Medical Center
Asheville, North Carolina, 28801
Seven Hills Women's Health
Cincinnati, Ohio, 45231
Women's Health Advantage
Fort Wayne, Indiana, 46825
Amy Brenner MD and Associates, LLC
Mason, Ohio, 45040
The Advance Gynecologic Surgery Institute
Naperville, Illinois, 60540
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Basinski LLC
Newburgh, Indiana, 47630
Premier Clinical Research
Spokane, Washington, 99202
Canada2 sites
Allan Centre
Calgary, Alberta, T2J 7G9
LaSalle Hospital
LaSalle, Quebec, H8P 1C1
Mexico1 site
Hospital Universitario de la Universidad Autónoma de Nuevo Leon
Monterrey, Nuevo León, 66460
About this study
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
- Being tested
- Cerene(R) Cryotherapy Device
- Keywords
- heavy menstrual bleeding, endometrial ablation
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerene(R) Cryotherapy DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Cryoablation | Experimental | Not described Receives: Device: Cerene(R) Cryotherapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Measured: 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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 12 Months
Investigator Evaluation of the Uterine Cavity
Measured: 12 Months
Investigator Assessment of Cavity Findings
Questions to the investigator
Measured: 12 Months
Anesthesia and Pain Medications at Treatment
Measured: 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.
Measured: Day of Treatment and Day One Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Channel Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842736
- Sponsor's protocol ID
- CIP-0101
- Acronym
- CLARITY
- Status last verified
- Dec 2020
- First submitted
- 21 Jul 2016
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 35983177Curlin 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.
PubMed 34839060Curlin 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.
PubMed 32835865
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT02842736
- Acronym / sponsor ID
- CLARITY / CIP-0101
- Conditions
- Menorrhagia
- Keywords
- heavy menstrual bleeding, endometrial ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Channel MedsystemsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cryoablation | Experimental | Device: Cerene(R) Cryotherapy Device |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- Pregnant or has a desire to conceive
- Endometrial hyperplasia as confirmed by histology
- Active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerene(R) Cryotherapy Device | Device | Endometrial Cryoablation |
Primary outcome
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Time frame: 12 months
Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
Time frame: 12 months
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.
6 secondary outcomes
Dysmennorhea
Time frame: 12 Months
Amenorrhea
Time frame: 12 Months
Investigator Evaluation of the Uterine Cavity
Time frame: 12 Months
Investigator Assessment of Cavity Findings
Time frame: 12 Months
Anesthesia and Pain Medications at Treatment
Time frame: Day of Treatment
Subject Rating of Pain During Treatment and Day One Post-Treatment
Time frame: Day of Treatment and Day One Post-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35983177Curlin 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.
- Derived from this study: PubMed 34839060Curlin 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.
- Derived from this study: PubMed 32835865Curlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerene(R) Cryotherapy Device in people with Menorrhagia, run by Channel Medsystems at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842736, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.