CLARITY: A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
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 |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Endometrial Cryoablation
|
Device: Cerene(R) Cryotherapy Device
|
Outcome Measures
Primary Outcome Measures
- 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 [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
- 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.
- 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.
- Investigator Evaluation of the Uterine Cavity [12 Months]
- Investigator Assessment of Cavity Findings [12 Months]
Questions to the investigator
- Anesthesia and Pain Medications at Treatment [Day of Treatment]
- 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
- Subjects' Report of Their Last Menstrual Period [36 months]
Subjects were asked to describe their last menstrual period
- Menstrual Impact Questionnaire [36 months]
Subjects' Report of Activity Limitations
- Premenstrual Symptoms Impact Survey [36 months]
Subjects' Report of Pre-Menstrual Symptoms (PMS)
- Subject Satisfaction [36 Months]
Subject's level of satisfaction with the results of her Cerene treatment
- Subject Recommendation [36 months]
Subjects' reported level of recommendation to a friend/family
- Procedure Time [Day of Treatment]
Device insertion to device removal
- Return to Normal Daily Activities [Two-Weeks]
Eligibility Criteria
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
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.- CIP-0101
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
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
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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
|
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%
|
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%
|
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%
|
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%
|
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%
|
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)
|
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
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 |
clinreg@channelmedsystems.com |
- CIP-0101