Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test (NCT NCT01740687)
NCT ID: NCT01740687
Last Updated: 2023-02-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
211 participants
Primary outcome timeframe
1 year after NovaSure Endometrial Ablation procedure
Results posted on
2023-02-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
211
|
|
Overall Study
Underwent NovaSure EA Treatment
|
209
|
|
Overall Study
COMPLETED
|
174
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
other reason
|
22
|
|
Overall Study
treatment not received
|
2
|
Baseline Characteristics
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Baseline characteristics by cohort
| Measure |
Essure + NovaSure
n=211 Participants
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test.
|
|---|---|
|
Age, Continuous
|
38.9 Years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after NovaSure Endometrial Ablation procedureOutcome measures
| Measure |
Essure + NovaSure
n=211 Participants
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test.
|
|---|---|
|
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
|
0 Pregnancy
|
PRIMARY outcome
Timeframe: 3 years after NovaSure Endometrial Ablation procedureOutcome measures
| Measure |
Essure + NovaSure
n=211 Participants
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test.
|
|---|---|
|
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
|
0 Pregnancy
|
SECONDARY outcome
Timeframe: After 3-year follow-upAn 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.
Outcome measures
| Measure |
Essure + NovaSure
n=211 Participants
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test.
|
|---|---|
|
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
Any AE
|
398 AEs
|
|
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
Any SAE
|
28 AEs
|
Adverse Events
Essure + NovaSure
Serious events: 18 serious events
Other events: 95 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Essure + NovaSure
n=211 participants at risk
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Cardiac disorders
Torsade de pointes
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Infections and infestations
Herpes simplex
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Infections and infestations
Pneumonia
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Nervous system disorders
Syncope
|
0.47%
1/211 • Number of events 3 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.95%
2/211 • Number of events 2 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.47%
1/211 • Number of events 1 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.4%
5/211 • Number of events 5 • Up to 3-year follow-up
|
Other adverse events
| Measure |
Essure + NovaSure
n=211 participants at risk
The group of women relying on Essure micro-inserts for permanent birth control when NovaSure was performed following a successful Essure Confirmation Test
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
7/211 • Number of events 7 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Constipation
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Nausea
|
4.3%
9/211 • Number of events 9 • Up to 3-year follow-up
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
General disorders
Fatigue
|
2.4%
5/211 • Number of events 5 • Up to 3-year follow-up
|
|
Infections and infestations
Bacterial vaginosis
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Infections and infestations
Bacterial vulvovaginitis
|
1.9%
4/211 • Number of events 4 • Up to 3-year follow-up
|
|
Infections and infestations
Fungal infection
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Infections and infestations
Urinary tract infection
|
5.2%
11/211 • Number of events 11 • Up to 3-year follow-up
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.8%
6/211 • Number of events 6 • Up to 3-year follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Nervous system disorders
Migraine
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Psychiatric disorders
Insomnia
|
1.9%
4/211 • Number of events 4 • Up to 3-year follow-up
|
|
Renal and urinary disorders
Stress urinary incontinence
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
1.4%
3/211 • Number of events 4 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Coital bleeding
|
1.9%
4/211 • Number of events 4 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.8%
8/211 • Number of events 8 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
3.3%
7/211 • Number of events 8 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Pelvic pain
|
11.8%
25/211 • Number of events 28 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
2.4%
5/211 • Number of events 5 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Uterine spasm
|
2.8%
6/211 • Number of events 6 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
15/211 • Number of events 17 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.7%
10/211 • Number of events 10 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Vaginal odour
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.4%
5/211 • Number of events 5 • Up to 3-year follow-up
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
4/211 • Number of events 4 • Up to 3-year follow-up
|
|
Vascular disorders
Hot flush
|
1.4%
3/211 • Number of events 3 • Up to 3-year follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60