Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essure+NovaSure | The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESS305 (Essure, BAY1454032) | Device | Essure Permanent Birth Control |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:
Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
Not provided
Not provided
Clinics and hospitals
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States | |||
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2016 | May 6, 2022 |
Not provided
Not provided
Not provided
Not provided
| NovaSure |
| Procedure |
Nova Sure Endometrial Ablation |
|
| After 3-year follow-up |
| Ocala |
| Florida |
| 34471 |
| United States |
| Decatur | Illinois | 62526 | United States |
| Fort Wayne | Indiana | 46825 | United States |
| Newburgh | Indiana | 47630 | United States |
| Easton | Maryland | 21601 | United States |
| Grand Blanc | Michigan | 48439 | United States |
| Maplewood | Minnesota | 55109 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Neptune City | New Jersey | 07753 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Englewood | Ohio | 45322 | United States |
| Mason | Ohio | 45040 | United States |
| Pottstown | Pennsylvania | 19464 | United States |
| Nashville | Tennessee | 37232 | United States |
| Norfolk | Virginia | 23507 | United States |
| Spokane | Washington | 99204 | United States |
| Underwent NovaSure EA Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate) | Posted | Number | Pregnancy | 1 year after NovaSure Endometrial Ablation procedure |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate) | Posted | Number | Pregnancy | 3 years after NovaSure Endometrial Ablation procedure |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | AEs | After 3-year follow-up |
|
|
Up to 3-year follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 211 | 18 | 211 | 95 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Coital bleeding | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Uterine spasm | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vaginal odour | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (24.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2021 | May 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|