Clinical trial NCT00737061: Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
Official title: A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reproductive Sterilization
Keywords: Female
Sterilization
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
Collaborators: name: QST Consultations, Ltd.
First posted: 2008-08-18
Enrollment: 770
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 1 Year Pregnancy Rate
timeFrame: 1 year
Secondary outcomes:
measure: Device Placement Rate
timeFrame: After First Treatment Attempt
measure: Device Placement Rate
timeFrame: Including Second Treatment Attempt
measure: Patient Satisfaction With Placement Procedure
timeFrame: 48 hours
measure: Patient Satisfaction With Device Wearing
timeFrame: Waiting Period (1-Month, 2-Months, 3-Months)
measure: Patient Satisfaction With Device Wearing
timeFrame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
measure: Patient Comfort With Placement Procedure
timeFrame: Post-Procedure
measure: Patient Comfort With Placement Procedure
timeFrame: 48 hours
measure: Patient Comfort With Device Wearing
timeFrame: Waiting Period (1-Month, 2-Months, 3-Months)
measure: Patient Comfort With Device Wearing
timeFrame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
measure: 3 Year Pregnancy Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Roseville
country: United States
facility: Kaiser Permanente
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
city: New Britain
country: United States
facility: Center for Fertility and Women's Health
state: Connecticut
city: Wellington
country: United States
facility: Institute for Women's Health and Body
state: Florida
city: Wichita
country: United States
facility: Center for Reproductive Medicine
state: Kansas
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Edina
country: United States
facility: Minnesota Gynecology and Surgery
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Durham
country: United States
facility: Duke Fertility Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor Research Institute
state: Texas
city: Milwaukee
country: United States
facility: Reproductive Specialty Center
state: Wisconsin
city: Randwick
country: Australia
facility: Royal Hospital for Women
state: New South Wales
city: Monterrey
country: Mexico
facility: Hospital Universitario UANL
state: Nuevo Leon
Study officials:
affiliation: Hologic, Inc.
name: Edward Evantash, MD
role: STUDY_DIRECTOR
References: