Post Approval NovaSure Essure Labeling Study

Status unconfirmed

Conditions studied: Menorrhagia

In brief

This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.

Key facts

Study ID: NCT01934244
Run by: Hologic, Inc.
People needed: 318
Starts: 2013-12-01
Expected to finish: 2019-01-01
Last updated by the study team: 2018-07-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Subject is 18 years of age or older and premenopausal.
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

You may not qualify if…

Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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