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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UNKNOWN
318 participants
OBSERVATIONAL
2013-12-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Per Protocol
All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed.
NovaSure Endometrial Ablation
The NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation.
Primary
All enrolled patients in whom the Novasure device was inserted.
No interventions assigned to this group
Intent to treat
All enrolled patients in which NovaSure device was attempted.
No interventions assigned to this group
Interventions
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NovaSure Endometrial Ablation
The NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation.
Eligibility Criteria
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Inclusion Criteria
* Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
* Subject has had an Essure Permanent Birth Control System procedure.
* The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
* Subject is able to provide informed consent
Exclusion Criteria
* Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
* Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
* Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
* Subject has an intrauterine device (IUD) currently in place.
* Subject has active pelvic inflammatory disease or history of recent pelvic infection.
* Subject has undiagnosed vaginal bleeding.
* ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
* Subject has uterine sound measurement greater than 10 cm.
* Subject with a uterine cavity length less than 4 cm.
* Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
* Subject is unable to comply with the protocol and be available for follow up
* In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.
18 Years
FEMALE
No
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Evantash, MD
Role: STUDY_DIRECTOR
Hologic, Inc.
Locations
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New Horizon Women's Care
Chandler, Arizona, United States
Westside Women's Care
Arvada, Colorado, United States
Physicians Care Clinical Research, LLC
Sarasota, Florida, United States
Western DuPage Obstetrics and Gynecology
Downers Grove, Illinois, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Minnesota Gynecology and Surgery
Edina, Minnesota, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Seven Hills Women's Center
Cincinnati, Ohio, United States
Amy Brenner MD & Associates, LLC
West Chester, Ohio, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Tennessee Women's Care
Nashville, Tennessee, United States
Rockwood Clinic, P.S.
Spokane, Washington, United States
Countries
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References
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Basinski CM, Price P, Burkhart J, Johnson J. Safety and Effectiveness of NovaSure(R) Endometrial Ablation After Placement of Essure(R) Micro-Inserts. J Gynecol Surg. 2012 Apr;28(2):83-88. doi: 10.1089/gyn.2011.0061.
Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.
Related Links
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Hologic, Inc. website
Other Identifiers
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S0112003
Identifier Type: -
Identifier Source: org_study_id
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