Clinical Evaluation of a Tubal Selective Delivery System

Inclusion Criteria: Literate in English Able to understand and sign an IRB-approved informed consent form Willing to complete a pre-procedure questionnaire Regular menstrual cycles (24- 38 days) Good general health Able and willing to comply with all study tests, procedures, and assessment tools Uterine sound size between 6 - 10 cm Agree to use a non-hormonal method of contraception or avoid vaginal intercourse during the catheter evaluation cycle In compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease. Alternatively, the subject must have had a colposcopy performed within the appropriate screen time frame, and prior to the study catheter insertion that showed no evidence of dysplasia requiring treatment or further diagnostic procedures or follow-up for at least 6 months Exclusion Criteria: Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test Currently using hormonal contraception. Must have at least one natural cycle (two menses) prior to participation if recently discontinued hormonal contraception. Currently using an intrauterine device (IUD). Must discontinue at least 30 days prior to Visit 2 Allergy or hypersensitive to radio-opaque contrast, ExEm foam, both doxycycline and azithromycin (allergy to one not exclusionary if can take the alternative), or lidocaine History or physical findings recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection History of involuntary female infertility History of gynecologic surgery involving the uterus, fallopian tubes, or ovaries (except single cesarean section) History of prior permanent contraception procedure (any technique, abdominal laparoscopic, or hysteroscopic) Pelvic exam findings considered clinically-significant by the investigator such as uterine fibroids, pelvic tenderness, or prolapse Inability to tolerate placement of a tenaculum and/or uterine sound during screening exam Any congenital or acquired uterine anomaly that may complicate study drug placement, such as: Submucosal uterine leiomyoma Asherman's syndromes Pedunculated polyps Bicornuate uterus Didelphys or uterine septa Any distortions of the uterine cavity (e.g., fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, use or removal of the TSDS. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and device placement Untreated or unresolved acute cervicitis or vaginitis Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS Screening transabdominal or transvaginal ultrasound findings with poor imaging quality, or anatomic abnormalities considered clinically important or likely to interfere with assessment of the test device, as assessed by the investigator