Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Lapa… (NCT03127722) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
United States990 participantsStarted 2017-05-03
Plain-language summary
This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:
* Pelvic and/or lower abdominal pain
* Abnormal uterine bleeding
* Surgical intervention (including "insert removal" and hysterectomy)
* Allergic, hypersensitivity, or autoimmune-like reactions
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who are at least 21 years of age;
* Subjects of all weights will be included;
* Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
* For the Essure group only:
• Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;
* For the laparoscopic tubal sterilization group only:
* Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.
Exclusion Criteria:
* Subjects who are post-menopausal;
* Subjects suspected of being or confirmed pregnant;
* Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
* Subjects uncertain about ending fertility;
* Subjects with an active upper or lower genital tract infection;
* Subjects with gynecologic malignancy (suspected or known);
* Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
* Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
* Subjects with unexpl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
Timeframe: Up to 60 months
2
Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization
Timeframe: Up to 60 months
3
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
Timeframe: Up to 60 months
4
Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders
Timeframe: Up to 60 months
5
Proportion of Subjects Undergoing Invasive Gynecologic Surgery After Essure Placement (Excluding Second Placement Attempts), Including Essure Removal Compared to Subjects Undergoing Invasive Gynecologic Surgery After Laparoscopic Tubal Sterilization