Women ages range 21 to 44 years desiring permanent contraception birth control contraception
Conditions
Interventions
Subjects meeting study eligibility requirements will be clinically assessed and
confirmed as appropriate for ESS505 placement.
ESS505 insert location will be evaluated and validated via TVU confirmat
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Females with age range 21 to 44 years; 2. Subjects seeking permanent contraception; 3. Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds); 4. Subjects willing to accept the risk of pregnancy occurring whilst relying solely on the ESS505 for contraception; 5. Subjects for whom medical physical history indicate bilateral viable and patent fallopian tubes; 6. Subjects are able to comply with the protocol required follow-up visits (e.g., 3-month clinic visit, and the 12-month telephone interview); 7. Subjects provide written informed consent prior to enrolment; 8. Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding their experience wearing the device; 9. Subjects who agree that anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies; 10. Subjects have no contraindications for use as described in the ESS505 Instructions for Use (*IFU*), i.e. women with bilateral proximal tubal occlusion, women who have undergone fallopian tube sterilization, women with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia, women who are post-menopausal, women with pelvic inflammatory disease, women who are pregnant or may become pregnant, women wih gynecologic malignancy, women with a general systemic disease or condition that could represent a risk, women who deliveres or terminated a pregnancy less than 6 weeks before Essure insert placement, women with a known allergy to contrast media, women with any general health condition that may represent, in the opinion of the physician, an increased potential risk associated with device use.
Exclusion criteria
Exclusion criteria: 1. Subjects with known proximal tubal occlusion in either fallopian tube; 2. Subjects who has undergone fallopian tube sterilisation procedure; 3. Subjects diagnosed with unicornuate uterus; 4. Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assess; 5. Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure. ;6. Subjects suspected of being or confirmed pregnant; 7. Subjects post-partum or undergone pregnancy termination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: - Following successful device placement (as confirmed via transvaginal ultrasound (*TVU*) confirmation test) performed at initial placement (day 0), assess occurrence of confirmed pregnancy at three months among subjects relying solely on ESS505 for contraception. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - Following successful device placement as confirmed via a TVU, assess occurrence of confirmed pregnancies at 12 months after device placement among subjects relying solely on ESS505 for contraception. - Assess severity and frequency of reported adverse events related to the device placement procedure. - Assess severity and frequency of adverse events reported among subjects in whom one or more ESS505 inserts are placed. | — |
Countries
Netherlands
Outcome results
None listed