Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
21–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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;
