Contraception, Menorrhagia
Conditions
Keywords
Endometrial Ablation, Permanent Sterilization, Essure, NovaSure, Prevention of Pregnancy
Brief summary
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
Detailed description
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Interventions
Essure Permanent Birth Control
PROCEDURENovaSure
Nova Sure Endometrial Ablation
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply. * Women experiencing menorrhagia due to benign causes * Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study) * Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia
Exclusion criteria
* All
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate) | 1 year after NovaSure Endometrial Ablation procedure |
| Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate) | 3 years after NovaSure Endometrial Ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts | After 3-year follow-up | An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure. |
Countries
United States
Participant flow
Pre-assignment details
A total of 220 participants were screened, of whom 215 participants met all the eligibility criteria at screening. NovaSure procedure was initiated for 211 participants, and 4 participants exited the study before the NovaSure attempt. Two participants for whom the procedure was initiated had the NovaSure procedure terminated before any energy was applied, thus 209 subjects underwent treatment with NovaSure. EA=Endometrial ablation.
Participants by arm
| Arm | Count |
|---|---|
| Essure + NovaSure The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test. | 211 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | other reason | 22 |
| Overall Study | treatment not received | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Essure + NovaSure |
|---|---|
| Age, Continuous | 38.9 Years STANDARD_DEVIATION 5.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 194 Participants |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 211 |
| other Total, other adverse events | 95 / 211 |
| serious Total, serious adverse events | 18 / 211 |
Outcome results
Primary
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Time frame: 1 year after NovaSure Endometrial Ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Essure + NovaSure | Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate) | 0 Pregnancy |
Comparison: predetermined study success threshold of 2.1% at 1 year
Primary
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Time frame: 3 years after NovaSure Endometrial Ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Essure + NovaSure | Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate) | 0 Pregnancy |
Comparison: predetermined study success threshold of 2.8% at 3 years
Secondary
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.
Time frame: After 3-year follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Essure + NovaSure | Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts | Any AE | 398 AEs |
| Essure + NovaSure | Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts | Any SAE | 28 AEs |