A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hologic, Inc.
- Enrollment
- 770
- Locations
- 16
- Primary Endpoint
- 1 Year Pregnancy Rate
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Adiana Transcervical Sterilization System
Single arm treatment
Intervention: Adiana Transcervical Sterilization System (Device)
Outcomes
Primary Outcomes
1 Year Pregnancy Rate
Time Frame: 1 year
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
Secondary Outcomes
- Device Placement Rate(Including Second Treatment Attempt)
- 3 Year Pregnancy Rate(3 years)
- Patient Satisfaction With Placement Procedure(48 hours)
- Patient Satisfaction With Device Wearing(Wearing Period (3-Months, 6-Months, 9-Months, 12-Months))
- Patient Comfort With Placement Procedure(48 hours)
- Patient Comfort With Device Wearing(Wearing Period (3-Months, 6-Months, 9-Months, 12-Months))
- Device Placement Rate(After First Treatment Attempt)
- Patient Satisfaction With Device Wearing(Waiting Period (1-Month, 2-Months, 3-Months))
- Patient Comfort With Placement Procedure(Post-Procedure)
- Patient Comfort With Device Wearing(Waiting Period (1-Month, 2-Months, 3-Months))