Trial Condition(s):
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test (ESS-NSPAS)
16975
Not Available
Not Available
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.
- 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
- 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: -- Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed vaginal bleeding, endometrial cancer, myomas, and polyps) -- Reproductive tract anatomical variants and/or pathology which could make the subject unsuitable for the Essure and/or NovaSure transcervical procedures - Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
Locations | Status | |
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Locations Investigative Site Pottstown, United States, 19464 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newburgh, United States, 47630 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Easton, United States, 21601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Decatur, United States, 62526 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Wayne, United States, 46825 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99204 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grand Blanc, United States, 48439 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89102 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ocala, United States, 34471 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27103 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mason, United States, 45040 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maplewood, United States, 55109 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Englewood, United States, 45322 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norfolk, United States, 23507 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Neptune, United States, 07753 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Trial Type:
Observational
Intervention Type:
Device
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1