Trial Outcomes & Findings for A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding (NCT NCT02842736)

NCT ID: NCT02842736

Last Updated: 2021-01-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	Endometrial Cryoablation Cerene(R) Cryotherapy Device
Overall Study STARTED	242
Overall Study Known Month 12 Outcome	230
Overall Study 24 Month Visit Performed	210
Overall Study COMPLETED	201
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Measure	Endometrial Cryoablation Cerene(R) Cryotherapy Device
Overall Study Lost to Follow-up	13
Overall Study Intervention for menstrual bleeding	17
Overall Study Withdrawal by Subject	4
Overall Study Pregnancy	3
Overall Study Hysterectomy for fibroids	2
Overall Study Hysterectomy for uterine prolapse	1
Overall Study IUD: Mirena	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Age, Continuous	40.1 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	242 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	190 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	43 Participants n=5 Participants
Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score	360.6 scores on a scale STANDARD_DEVIATION 332.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The Intent-to-Treat (ITT) population is comprised of all patients who successfully completed screening and presented on the day of treatment.

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events Serious adverse events	7 Reports of events
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events Serious device-related adverse events	0 Reports of events

PRIMARY outcome

Timeframe: 12 months

Population: The Intent-to-Treat (ITT) population comprised all patients who successfully completed screening and presented on the day of treatment.

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.

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75	186 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Endometrial Cryoablation n=230 Participants Cerene(R) Cryotherapy Device
Dysmennorhea 0 - No symptom	74 Participants
Dysmennorhea 1 - Very Mild	70 Participants
Dysmennorhea 2 - Mild	40 Participants
Dysmennorhea 3 - Moderate	33 Participants
Dysmennorhea 4 - Severe	10 Participants
Dysmennorhea 5 - Very Severe	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Amenorrhea	25 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: 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.

Outcome measures

Measure	Endometrial Cryoablation n=223 Participants Cerene(R) Cryotherapy Device
Investigator Evaluation of the Uterine Cavity Uterine cavity entry with a hysteroscope · YES	220 Participants
Investigator Evaluation of the Uterine Cavity Uterine cavity entry with a hysteroscope · NO	3 Participants
Investigator Evaluation of the Uterine Cavity Full visualization of the uterine cavity · YES	204 Participants
Investigator Evaluation of the Uterine Cavity Full visualization of the uterine cavity · NO	19 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Investigators' assessment was based on the 204 subjects whose cavities could be fully visualized (see Secondary Outcome: Investigator Evaluation of the Uterine Cavity).

Questions to the investigator

Outcome measures

Measure	Endometrial Cryoablation n=204 Participants Cerene(R) Cryotherapy Device
Investigator Assessment of Cavity Findings Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? · YES	178 Participants
Investigator Assessment of Cavity Findings Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? · NO	26 Participants
Investigator Assessment of Cavity Findings Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? · YES	195 Participants
Investigator Assessment of Cavity Findings Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? · NO	9 Participants

SECONDARY outcome

Timeframe: Day of Treatment

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Anesthesia and Pain Medications at Treatment Paracervical block only	20 Participants
Anesthesia and Pain Medications at Treatment Paracervical block with nonsteroidal anti-inflammatories	48 Participants
Anesthesia and Pain Medications at Treatment Paracervical block with oral narcotics and/or anxiolytics	167 Participants
Anesthesia and Pain Medications at Treatment Paracervical block with intravenous sedation	7 Participants
Anesthesia and Pain Medications at Treatment General anesthesia	0 Participants

SECONDARY outcome

Timeframe: Day of Treatment and Day One Post-Treatment

Population: 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.

Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Subject Rating of Pain During Treatment and Day One Post-Treatment After Liner Deployment (before endometrial ablation was initiated)	1 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment After 1 Minute of Ablation	2 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment End of Ablation	1 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment 15-30 Minutes Post-Procedure	2 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment Before Device Insertion	1 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment After Device Insertion	2 units on a scale Interval 0.0 to 10.0
Subject Rating of Pain During Treatment and Day One Post-Treatment At Time of Discharge	2 units on a scale Interval 0.0 to 8.0
Subject Rating of Pain During Treatment and Day One Post-Treatment Day 1	0 units on a scale Interval 0.0 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months

Subjects were asked to describe their last menstrual period

Outcome measures

Measure	Endometrial Cryoablation n=201 Participants Cerene(R) Cryotherapy Device
Subjects' Report of Their Last Menstrual Period I no longer get my period	29 Participants
Subjects' Report of Their Last Menstrual Period My periods are lighter than normal	99 Participants
Subjects' Report of Their Last Menstrual Period My periods are normal	50 Participants
Subjects' Report of Their Last Menstrual Period I continue to have heavy periods	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months

Subjects' Report of Activity Limitations

Outcome measures

Measure	Endometrial Cryoablation n=201 Participants Cerene(R) Cryotherapy Device
Menstrual Impact Questionnaire Free of limitation in activity at moderate or higher level	182 Participants
Menstrual Impact Questionnaire Limitation in activity is present at moderate or higher level	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months

Subjects' Report of Pre-Menstrual Symptoms (PMS)

Outcome measures

Measure	Endometrial Cryoablation n=201 Participants Cerene(R) Cryotherapy Device
Premenstrual Symptoms Impact Survey Free of PMS often, most often, very often, or all of the time	171 Participants
Premenstrual Symptoms Impact Survey PMS occur often, most often, very often, or all of the time	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Months

Population: Of 201 subjects who completed the study, 181 reported their level of satisfaction

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

Outcome measures

Measure	Endometrial Cryoablation n=181 Participants Cerene(R) Cryotherapy Device
Subject Satisfaction Satisfied or very satisfied	153 Participants
Subject Satisfaction Dissatisfied or very dissatisfied	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months

Population: Of 201 subjects who completed the study, 193 reported their level of recommendation

Subjects' reported level of recommendation to a friend/family

Outcome measures

Measure	Endometrial Cryoablation n=193 Participants Cerene(R) Cryotherapy Device
Subject Recommendation Definitely or maybe recommend	175 Participants
Subject Recommendation Probably not or definitely not recommend	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of Treatment

Device insertion to device removal

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Procedure Time	6.9 minutes Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Two-Weeks

Outcome measures

Measure	Endometrial Cryoablation n=242 Participants Cerene(R) Cryotherapy Device
Return to Normal Daily Activities	2.0 days Standard Deviation 2.3

Adverse Events

Endometrial Cryoablation

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Endometrial Cryoablation n=242 participants at risk Cerene(R) Cryotherapy Device
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.41% 1/242 • Number of events 1 • 36 Months 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.
Hepatobiliary disorders Acute Cholecystitis	0.41% 1/242 • Number of events 1 • 36 Months 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.
Hepatobiliary disorders Bile Duct Obstruction	0.41% 1/242 • Number of events 1 • 36 Months 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.
Nervous system disorders Stroke	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Menorrhagia	0.41% 1/242 • Number of events 1 • 36 Months 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.
Gastrointestinal disorders Chronic Constipation	0.41% 1/242 • Number of events 1 • 36 Months 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.
Nervous system disorders Paresthesia of limbs	0.41% 1/242 • Number of events 1 • 36 Months 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.

Other adverse events

Measure	Endometrial Cryoablation n=242 participants at risk Cerene(R) Cryotherapy Device
Infections and infestations Bacterial vaginosis	2.9% 7/242 • Number of events 7 • 36 Months 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.
Nervous system disorders Presyncope	1.2% 3/242 • Number of events 4 • 36 Months 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.
Reproductive system and breast disorders Uterine cramps	3.3% 8/242 • Number of events 8 • 36 Months 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.
Gastrointestinal disorders Emesis	0.41% 1/242 • Number of events 1 • 36 Months 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.
General disorders Fever	0.41% 1/242 • Number of events 1 • 36 Months 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.
Infections and infestations Endometritis	0.41% 1/242 • Number of events 1 • 36 Months 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.
Infections and infestations Vulvovaginitis Streptococcal	0.41% 1/242 • Number of events 1 • 36 Months 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.
Musculoskeletal and connective tissue disorders Groin pain	0.41% 1/242 • Number of events 1 • 36 Months 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.
Renal and urinary disorders Urinary incontinence	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Dyspareunia	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Menstrual cramps	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Pelvic pain	1.7% 4/242 • Number of events 4 • 36 Months 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.
Reproductive system and breast disorders Uterine tenderness	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Vaginal discharge	0.83% 2/242 • Number of events 2 • 36 Months 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.
Vascular disorders Hypertension	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Adenomyosis	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Dysmenorrhea	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Endometritis	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Intermenstrual bleeding	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Menorrhagia	6.2% 15/242 • Number of events 15 • 36 Months 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.
Reproductive system and breast disorders Pelvic cramping	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Polycystic ovarian disease	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Pos- coital bleeding	0.41% 1/242 • Number of events 1 • 36 Months 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.
Pregnancy, puerperium and perinatal conditions Pregnancy; uterine	0.41% 1/242 • Number of events 1 • 36 Months 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.
Pregnancy, puerperium and perinatal conditions Pregnancy; uterine terminated	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Right breast mass	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Uterine fibroids	0.83% 2/242 • Number of events 2 • 36 Months 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.
Reproductive system and breast disorders Uterine prolapse Stage 2	0.41% 1/242 • Number of events 1 • 36 Months 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.
Reproductive system and breast disorders Vaginal infection and/or discharge	4.5% 11/242 • Number of events 11 • 36 Months 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.
Reproductive system and breast disorders Vaginal/vulvar pruritus	0.83% 2/242 • Number of events 2 • 36 Months 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.

Additional Information

Clinical and Regulatory Affairs

Channel Medsystems

Phone: 510-338-9301

Email: clinreg@channelmedsystems.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER