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

NCT00737061 | Terminated Results DMC

• 1 other identifier: P0071
• Study Type: interventional
• Target: 770
• Locations: 3 countries
• Sites: 16

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.

Conditions

Reproductive Sterilization

Keywords

Female; Sterilization

Outcome Measures

Primary Outcomes (1)

• 1 Year Pregnancy Rate

  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.

  1 year

Secondary Outcomes (10)

• Device Placement Rate

  After First Treatment Attempt

• Device Placement Rate

  Including Second Treatment Attempt

• Patient Satisfaction With Placement Procedure

  48 hours

• Patient Satisfaction With Device Wearing

  Waiting Period (1-Month, 2-Months, 3-Months)

• Patient Satisfaction With Device Wearing

  Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)

Study Arms (1)

Adiana Transcervical Sterilization System

EXPERIMENTAL

Single arm treatment

Device: Adiana Transcervical Sterilization System

Interventions

Adiana Transcervical Sterilization System DEVICE

Implantation of silicone matrix in fallopian tubes

Adiana Transcervical Sterilization System

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead
• QST Consultations, Ltd.: collaborator

Study Sites (16)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Kaiser Permanente

Roseville, California, 95661, United States

Location

Kaiser Permanente

San Rafael, California, 94903, United States

Location

Reproductive Science Center

San Ramon, California, 94583, United States

Location

Center for Fertility and Women's Health

New Britain, Connecticut, 06050, United States

Location

Institute for Women's Health and Body

Wellington, Florida, 33414, United States

Location

Center for Reproductive Medicine

Wichita, Kansas, 67226, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Minnesota Gynecology and Surgery

Edina, Minnesota, 55435, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Duke Fertility Center

Durham, North Carolina, 27713, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Research Institute

Fort Worth, Texas, 76104, United States

Location

Reproductive Specialty Center

Milwaukee, Wisconsin, 53211, United States

Location

Royal Hospital for Women

Randwick, New South Wales, 2031, Australia

Location

Hospital Universitario UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Limitations and Caveats

At the time of analysis, 481 completed 3 years. Due to the cumulative nature of the analysis, subjects may be lost to follow-up at one time and return to follow-up at a subsequent point. All subjects who have not withdrawn consent will be followed.

Results Point of Contact

• Title: Edward Evantash, MD, Medical Director, Vice President Medical Affairs
• Organization: Hologic, Inc.

edward.evantash@hologic.com

508-263-8475

Study Officials

• Edward Evantash, MD

  Hologic, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: November 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: February 4, 2013
• Last Updated: September 8, 2017
• Results First Posted: January 25, 2013

Record last verified: 2017-08

Locations

AU (1); US (14); ME (1)