- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934244
Post Approval NovaSure Essure Labeling Study (PANEL)
July 26, 2018 updated by: Hologic, Inc.
Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
318
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Chandler, Arizona, United States, 85224
- New Horizon Women's Care
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Colorado
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Arvada, Colorado, United States, 80005
- Westside Women's Care
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Florida
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Sarasota, Florida, United States, 34239
- Physicians Care Clinical Research, LLC
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Illinois
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Downers Grove, Illinois, United States, 60515
- Western DuPage Obstetrics and Gynecology
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Michigan
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Dearborn, Michigan, United States, 48124
- Oakwood Hospital and Medical Center
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Saginaw, Michigan, United States, 48604
- Saginaw Valley Medical Research Group, LLC
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Minnesota
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Edina, Minnesota, United States, 55435
- Minnesota Gynecology and Surgery
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Bosque Women's Care
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Lyndhurst Clinical Research
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Ohio
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Cincinnati, Ohio, United States, 45238
- Seven Hills Women's Center
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West Chester, Ohio, United States, 45069
- Amy Brenner MD & Associates, LLC
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Medical Research, Llc
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Nashville, Tennessee, United States, 37203
- Tennessee Women's Care
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Washington
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Spokane, Washington, United States, 99204
- Rockwood Clinic, P.S.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Per Protocol
All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed.
|
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.
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Primary
All enrolled patients in whom the Novasure device was inserted.
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Intent to treat
All enrolled patients in which NovaSure device was attempted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Essure micro-insert removal with NovaSure device
Time Frame: NovaSure procedure visit (Day 1)
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At the end of the NovaSure treatment and upon removal of the NovaSure device, the device will be directly observed to see if any Essure micro-insert(s) is(are) attached.
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NovaSure procedure visit (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and percentage of subjects with adverse events
Time Frame: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
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Adverse events reported during and/or immediately post operative the NovaSure procedure. Adverse events reported up to 1 month after the NovaSure procedure |
NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Edward Evantash, MD, Hologic, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2013
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
August 26, 2013
First Submitted That Met QC Criteria
September 3, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 26, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S0112003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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