Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT00737061
Eligibility Criteria:
Inclusion Criteria:
* • Women aged 18 to 45
* Women who are seeking permanent contraception
* Women who are at risk of becoming pregnant
* Willing to risk becoming pregnant when relying on the Adiana device for contraception
* Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography
* Willing to keep a coital/menstrual log
* Have at least one confirmed pregnancy and one living child
* Monogamous relationship with a partner who has proven fertility
* Sexually active (at least 4 acts of intercourse per month)
* Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception
* Willing and able to maintain in regular contact with the investigator
* Women with regular, cyclical menses within 2 months prior to the device placement procedure
* Able to provide informed consent
Exclusion Criteria:
* Women who are unsure of their desire to end their fertility
* Presence of gross genital infection, including sepsis
* Presence of chlamydia, gonorrhea or syphilis
* Presence of genital cancer (note: CIN1 is acceptable)
* Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions
* History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease
* Women with unresolved tubal, ovarian or endometrial pathology
* Uterine neoplasia or precursors to neoplasia
* Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months
* Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy
* Currently taking immunosuppressive medications including steroids
* Pregnancy
* Uterine perforation within the last 3 months
* Contraindications for surgical methods of sterilization
* Less than three months have passed since the last delivery or abortion
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00737061
Study Brief:
Protocol Section:
NCT00737061