Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization) (EASE)

Hologic

Status: Terminated

Conditions: Reproductive Sterilization

Treatments: Device: Adiana Transcervical Sterilization System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00737061

P0071

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Full description

Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up.

Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.

Enrollment: 770 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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770 participants in 1 patient group

Adiana Transcervical Sterilization System

Experimental group

Description:

Single arm treatment

Treatment:

Device: Adiana Transcervical Sterilization System