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

Sponsor
Channel Medsystems (Industry)
Overall Status
Completed
CT.gov ID
NCT02842736
Collaborator
(none)
242
12
1
49
20.2
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cerene(R) Cryotherapy Device
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endometrial Cryoablation

Device: Cerene(R) Cryotherapy Device

Outcome Measures

Primary Outcome Measures

  1. Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events [12 months]

  2. Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75 [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.

Secondary Outcome Measures

  1. Dysmennorhea [12 Months]

    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.

  2. Amenorrhea [12 Months]

    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.

  3. Investigator Evaluation of the Uterine Cavity [12 Months]

  4. Investigator Assessment of Cavity Findings [12 Months]

    Questions to the investigator

  5. Anesthesia and Pain Medications at Treatment [Day of Treatment]

  6. Subject Rating of Pain During Treatment and Day One Post-Treatment [Day of 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.

Other Outcome Measures

  1. Subjects' Report of Their Last Menstrual Period [36 months]

    Subjects were asked to describe their last menstrual period

  2. Menstrual Impact Questionnaire [36 months]

    Subjects' Report of Activity Limitations

  3. Premenstrual Symptoms Impact Survey [36 months]

    Subjects' Report of Pre-Menstrual Symptoms (PMS)

  4. Subject Satisfaction [36 Months]

    Subject's level of satisfaction with the results of her Cerene treatment

  5. Subject Recommendation [36 months]

    Subjects' reported level of recommendation to a friend/family

  6. Procedure Time [Day of Treatment]

    Device insertion to device removal

  7. Return to Normal Daily Activities [Two-Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Channel Medsystems

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Channel Medsystems
ClinicalTrials.gov Identifier:
NCT02842736
Other Study ID Numbers:
  • CIP-0101
First Posted:
Jul 25, 2016
Last Update Posted:
Jan 5, 2021
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Channel Medsystems
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Period Title: Overall Study
STARTED 242
Known Month 12 Outcome 230
24 Month Visit Performed 210
COMPLETED 201
NOT COMPLETED 41

Baseline Characteristics

Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Overall Participants 242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
40.1
(5.1)
Sex: Female, Male (Count of Participants)
Female
242
100%
Male
0
0%
Race/Ethnicity, Customized (Count of Participants)
White
190
78.5%
Black or African American
6
2.5%
American Indian or Alaska Native
3
1.2%
Other
43
17.8%
Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
360.6
(332.1)

Outcome Measures

1. Primary Outcome
Title Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Description
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
The Intent-to-Treat (ITT) population is comprised of all patients who successfully completed screening and presented on the day of treatment.
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Serious adverse events
7
Serious device-related adverse events
0
2. Primary Outcome
Title Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
Description 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.
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
The Intent-to-Treat (ITT) population comprised all patients who successfully completed screening and presented on the day of treatment.
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Count of Participants [Participants]
186
76.9%
3. Secondary Outcome
Title Dysmennorhea
Description 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.
Time Frame 12 Months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 230
0 - No symptom
74
30.6%
1 - Very Mild
70
28.9%
2 - Mild
40
16.5%
3 - Moderate
33
13.6%
4 - Severe
10
4.1%
5 - Very Severe
3
1.2%
4. Secondary Outcome
Title Amenorrhea
Description 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.
Time Frame 12 Months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Count of Participants [Participants]
25
10.3%
5. Secondary Outcome
Title Investigator Evaluation of the Uterine Cavity
Description
Time Frame 12 Months

Outcome Measure Data

Analysis Population Description
Of 230 subjects with a known Month 12 outcome, 223 underwent a hysteroscopy at Month 12. The remaining seven (7) subjects encountered scheduling conflicts or illness.
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 223
YES
220
90.9%
NO
3
1.2%
YES
204
84.3%
NO
19
7.9%
6. Secondary Outcome
Title Investigator Assessment of Cavity Findings
Description Questions to the investigator
Time Frame 12 Months

Outcome Measure Data

Analysis Population Description
Investigators' assessment was based on the 204 subjects whose cavities could be fully visualized (see Secondary Outcome: Investigator Evaluation of the Uterine Cavity).
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 204
YES
178
73.6%
NO
26
10.7%
YES
195
80.6%
NO
9
3.7%
7. Secondary Outcome
Title Anesthesia and Pain Medications at Treatment
Description
Time Frame Day of Treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Paracervical block only
20
8.3%
Paracervical block with nonsteroidal anti-inflammatories
48
19.8%
Paracervical block with oral narcotics and/or anxiolytics
167
69%
Paracervical block with intravenous sedation
7
2.9%
General anesthesia
0
0%
8. Secondary Outcome
Title Subject Rating of Pain During Treatment and Day One Post-Treatment
Description Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.
Time Frame Day of Treatment and Day One Post-Treatment

Outcome Measure Data

Analysis Population Description
Some subjects did not provide a pain score rating due to sedation. One subject did not provide a pain score at her Day 1 visit.
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Before Device Insertion
1
After Device Insertion
2
After Liner Deployment (before endometrial ablation was initiated)
1
After 1 Minute of Ablation
2
End of Ablation
1
15-30 Minutes Post-Procedure
2
At Time of Discharge
2
Day 1
0
9. Other Pre-specified Outcome
Title Subjects' Report of Their Last Menstrual Period
Description Subjects were asked to describe their last menstrual period
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 201
I no longer get my period
29
12%
My periods are lighter than normal
99
40.9%
My periods are normal
50
20.7%
I continue to have heavy periods
23
9.5%
10. Other Pre-specified Outcome
Title Menstrual Impact Questionnaire
Description Subjects' Report of Activity Limitations
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 201
Free of limitation in activity at moderate or higher level
182
75.2%
Limitation in activity is present at moderate or higher level
19
7.9%
11. Other Pre-specified Outcome
Title Premenstrual Symptoms Impact Survey
Description Subjects' Report of Pre-Menstrual Symptoms (PMS)
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 201
Free of PMS often, most often, very often, or all of the time
171
70.7%
PMS occur often, most often, very often, or all of the time
30
12.4%
12. Other Pre-specified Outcome
Title Subject Satisfaction
Description Subject's level of satisfaction with the results of her Cerene treatment
Time Frame 36 Months

Outcome Measure Data

Analysis Population Description
Of 201 subjects who completed the study, 181 reported their level of satisfaction
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 181
Satisfied or very satisfied
153
63.2%
Dissatisfied or very dissatisfied
28
11.6%
13. Other Pre-specified Outcome
Title Subject Recommendation
Description Subjects' reported level of recommendation to a friend/family
Time Frame 36 months

Outcome Measure Data

Analysis Population Description
Of 201 subjects who completed the study, 193 reported their level of recommendation
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 193
Definitely or maybe recommend
175
72.3%
Probably not or definitely not recommend
18
7.4%
14. Other Pre-specified Outcome
Title Procedure Time
Description Device insertion to device removal
Time Frame Day of Treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Mean (Standard Deviation) [minutes]
6.9
(1.1)
15. Other Pre-specified Outcome
Title Return to Normal Daily Activities
Description
Time Frame Two-Weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
Measure Participants 242
Mean (Standard Deviation) [days]
2.0
(2.3)

Adverse Events

Time Frame 36 Months
Adverse Event Reporting Description Adverse event information was collected throughout the study at each subject contact. All serious adverse events observed in the study are reported in "Serious Adverse Events" below. "Other (Not Including Serious) Adverse Events" below presents a summary of (1) for up to 12-month follow-up, device and/or procedure-related non-serious adverse events occurring in more than 1% of subjects and (2) for post 12-Month follow-up, all gynecologic adverse events.
Arm/Group Title Endometrial Cryoablation
Arm/Group Description Cerene(R) Cryotherapy Device
All Cause Mortality
Endometrial Cryoablation
Affected / at Risk (%) # Events
Total 0/242 (0%)
Serious Adverse Events
Endometrial Cryoablation
Affected / at Risk (%) # Events
Total 6/242 (2.5%)
Gastrointestinal disorders
Chronic Constipation 1/242 (0.4%) 1
Hepatobiliary disorders
Acute Cholecystitis 1/242 (0.4%) 1
Bile Duct Obstruction 1/242 (0.4%) 1
Nervous system disorders
Stroke 1/242 (0.4%) 1
Paresthesia of limbs 1/242 (0.4%) 1
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy 1/242 (0.4%) 1
Reproductive system and breast disorders
Menorrhagia 1/242 (0.4%) 1
Other (Not Including Serious) Adverse Events
Endometrial Cryoablation
Affected / at Risk (%) # Events
Total 29/242 (12%)
Gastrointestinal disorders
Emesis 1/242 (0.4%) 1
General disorders
Fever 1/242 (0.4%) 1
Infections and infestations
Bacterial vaginosis 7/242 (2.9%) 7
Endometritis 1/242 (0.4%) 1
Vulvovaginitis Streptococcal 1/242 (0.4%) 1
Musculoskeletal and connective tissue disorders
Groin pain 1/242 (0.4%) 1
Nervous system disorders
Presyncope 3/242 (1.2%) 4
Pregnancy, puerperium and perinatal conditions
Pregnancy; uterine 1/242 (0.4%) 1
Pregnancy; uterine terminated 1/242 (0.4%) 1
Renal and urinary disorders
Urinary incontinence 2/242 (0.8%) 2
Reproductive system and breast disorders
Uterine cramps 8/242 (3.3%) 8
Dyspareunia 1/242 (0.4%) 1
Menstrual cramps 2/242 (0.8%) 2
Pelvic pain 2/242 (0.8%) 2
Uterine tenderness 1/242 (0.4%) 1
Vaginal discharge 2/242 (0.8%) 2
Adenomyosis 1/242 (0.4%) 1
Dysmenorrhea 2/242 (0.8%) 2
Dyspareunia 1/242 (0.4%) 1
Endometritis 1/242 (0.4%) 1
Intermenstrual bleeding 2/242 (0.8%) 2
Menorrhagia 15/242 (6.2%) 15
Pelvic cramping 2/242 (0.8%) 2
Pelvic pain 4/242 (1.7%) 4
Polycystic ovarian disease 1/242 (0.4%) 1
Pos- coital bleeding 1/242 (0.4%) 1
Right breast mass 1/242 (0.4%) 1
Uterine fibroids 2/242 (0.8%) 2
Uterine prolapse Stage 2 1/242 (0.4%) 1
Vaginal infection and/or discharge 11/242 (4.5%) 11
Vaginal/vulvar pruritus 2/242 (0.8%) 2
Vascular disorders
Hypertension 2/242 (0.8%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigators have the right to publish their data, with the following provisions: (1) investigators at academic centers have a time frame for submission of their manuscript, or other, to Sponsor prior to publication and (2) investigators at private clinics can request prior written consent.

Results Point of Contact

Name/Title Clinical and Regulatory Affairs
Organization Channel Medsystems
Phone 510-338-9301
Email clinreg@channelmedsystems.com
Responsible Party:
Channel Medsystems
ClinicalTrials.gov Identifier:
NCT02842736
Other Study ID Numbers:
  • CIP-0101
First Posted:
Jul 25, 2016
Last Update Posted:
Jan 5, 2021
Last Verified:
Dec 1, 2020