Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
NCT ID: NCT01948882
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
660 participants
INTERVENTIONAL
2013-09-30
2024-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ESS505
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
ESS505 (BAY1454033)
Interventions
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ESS505 (BAY1454033)
Eligibility Criteria
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Inclusion Criteria
* Body weight within range of 90-300 lbs (40 - 136 kg)
* Sexually active (minimum of 4 coital acts per cycle)
* Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
* Medical history indicates bilateral viable and patent fallopian tubes
* Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
Exclusion Criteria
* Suspected or confirmed pregnancy
* Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
* Past fallopian tube sterilization procedure and/or total or partial salpingectomies
* Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
* Currently taking corticosteroids
* Known allergy to all contrast media available for use in hysterosalpingogram
* Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
* Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
21 Years
44 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Aurora, Colorado, United States
Denver, Colorado, United States
Wellington, Florida, United States
Fort Wayne, Indiana, United States
Newburgh, Indiana, United States
Saginaw, Michigan, United States
Rochester, Minnesota, United States
New York, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Cincinnati, Ohio, United States
Columbia, Ohio, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Hamilton, Ontario, Canada
Regina, Saskatchewan, Canada
Zwolle, , Netherlands
L'Hospitalet de Llobregat, Barcelona, Spain
Córdoba, , Spain
Countries
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Other Identifiers
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16973
Identifier Type: -
Identifier Source: org_study_id
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