Post Approval NovaSure Essure Labeling Study (PANEL)

Hologic

Status

Unknown

Conditions

Menorrhagia

Treatments

Device: NovaSure Endometrial Ablation

Study type

Observational

Funder types

Industry

Identifiers

NCT01934244

S0112003

Details and patient eligibility

About

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.

Full description

A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.

Enrollment

318 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.