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

This study has been terminated.
(Product Pre-Market Approval withdrawn)
Sponsor:
Collaborator:
QST Consultations, Ltd.
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00737061
First received: August 14, 2008
Last updated: February 7, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Reproductive Sterilization
Device: Adiana Transcervical Sterilization System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • 1 Year Pregnancy Rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Device Placement Rate [ Time Frame: After First Treatment Attempt ] [ Designated as safety issue: No ]
    Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.

  • Device Placement Rate [ Time Frame: Including Second Treatment Attempt ] [ Designated as safety issue: No ]
    Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.

  • Patient Satisfaction With Placement Procedure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.

  • Patient Satisfaction With Device Wearing [ Time Frame: Waiting Period (1-Month, 2-Months, 3-Months) ] [ Designated as safety issue: No ]
    Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.

  • Patient Satisfaction With Device Wearing [ Time Frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months) ] [ Designated as safety issue: No ]
    Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.

  • Patient Comfort With Placement Procedure [ Time Frame: Post-Procedure ] [ Designated as safety issue: No ]
    Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.

  • Patient Comfort With Placement Procedure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.

  • Patient Comfort With Device Wearing [ Time Frame: Waiting Period (1-Month, 2-Months, 3-Months) ] [ Designated as safety issue: No ]
    Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.

  • Patient Comfort With Device Wearing [ Time Frame: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months) ] [ Designated as safety issue: No ]
    Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.

  • 3 Year Pregnancy Rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. 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 who have been followed for up to 3 years.


Enrollment: 770
Study Start Date: November 2002
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adiana Transcervical Sterilization System
Single arm treatment
Device: Adiana Transcervical Sterilization System
Implantation of silicone matrix in 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737061

Locations
United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015
United States, California
Kaiser Permanente
Roseville, California, United States, 95661
Kaiser Permanente
San Rafael, California, United States, 94903
Reproductive Science Center
San Ramon, California, United States, 94583
United States, Connecticut
Center for Fertility and Women's Health
New Britain, Connecticut, United States, 06050
United States, Florida
Institute for Women's Health and Body
Wellington, Florida, United States, 33414
United States, Kansas
Center for Reproductive Medicine
Wichita, Kansas, United States, 67226
United States, Massachusetts
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, Minnesota
Minnesota Gynecology and Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, North Carolina
Duke Fertility Center
Durham, North Carolina, United States, 27713
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Research Institute
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Reproductive Specialty Center
Milwaukee, Wisconsin, United States, 53211
Australia, New South Wales
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031
Mexico
Hospital Universitario UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hologic, Inc.
QST Consultations, Ltd.
Investigators
Study Director: Edward Evantash, MD Hologic, Inc.
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT00737061     History of Changes
Other Study ID Numbers: P0071
Study First Received: August 14, 2008
Results First Received: August 26, 2009
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hologic, Inc.:
Female
Sterilization

Additional relevant MeSH terms:
Disinfectants
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014