Status:
TERMINATED
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
Lead Sponsor:
Hologic, Inc.
Collaborating Sponsors:
QST Consultations, Ltd.
Conditions:
Reproductive Sterilization
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 ...
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 foll...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2013
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT00737061
Start Date
November 1 2002
End Date
February 4 2013
Last Update
September 8 2017
Active Locations (16)
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1
Women's Health Research
Phoenix, Arizona, United States, 85015
2
Kaiser Permanente
Roseville, California, United States, 95661
3
Kaiser Permanente
San Rafael, California, United States, 94903
4
Reproductive Science Center
San Ramon, California, United States, 94583