Clinical trial NCT01934244: Post Approval NovaSure Essure Labeling Study
Official title: Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menorrhagia
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women 18 years of age or older who have abnormal uterine bleeding and are candidates for a NovaSure Endometrial Ablation that have already had an Essure Permanent Birth Control system procedure and an Essure Confirmation Test that has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Essure micro-insert removal with NovaSure device
timeFrame: NovaSure procedure visit (Day 1)
Secondary outcomes:
measure: Number and percentage of subjects with adverse events
timeFrame: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizon Women's Care
state: Arizona
city: Arvada
country: United States
facility: Westside Women's Care
state: Colorado
city: Sarasota
country: United States
facility: Physicians Care Clinical Research, LLC
state: Florida
city: Downers Grove
country: United States
facility: Western DuPage Obstetrics and Gynecology
state: Illinois
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Edina
country: United States
facility: Minnesota Gynecology and Surgery
state: Minnesota
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Seven Hills Women's Center
state: Ohio
city: West Chester
country: United States
facility: Amy Brenner MD & Associates, LLC
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Women's Care
state: Tennessee
city: Spokane
country: United States
facility: Rockwood Clinic, P.S.
state: Washington
Study officials:
affiliation: Hologic, Inc.
name: Edward Evantash, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.