Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Approval NovaSure Essure Labeling Study (PANEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934244
Recruitment Status : Unknown
Verified July 2018 by Hologic, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : September 4, 2013
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.

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.

Condition or disease Intervention/treatment
Menorrhagia Device: NovaSure Endometrial Ablation

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
Actual Study Start Date : December 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2019

Group/Cohort Intervention/treatment
Per Protocol
All enrolled patients in which all inclusion/exclusion criteria were met and the NovaSure endometrial ablation was completed.
Device: 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.
Intent to treat
All enrolled patients in which NovaSure device was attempted.



Primary Outcome Measures :
  1. Rate of Essure micro-insert removal with NovaSure device [ Time Frame: NovaSure procedure visit (Day 1) ]
    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.


Secondary Outcome Measures :
  1. Number and percentage of subjects with adverse events [ Time Frame: NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure ]

    Adverse events reported during and/or immediately post operative the NovaSure procedure.

    Adverse events reported up to 1 month after the NovaSure procedure




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934244


Locations
Layout table for location information
United States, Arizona
New Horizon Women's Care
Chandler, Arizona, United States, 85224
United States, Colorado
Westside Women's Care
Arvada, Colorado, United States, 80005
United States, Florida
Physicians Care Clinical Research, LLC
Sarasota, Florida, United States, 34239
United States, Illinois
Western DuPage Obstetrics and Gynecology
Downers Grove, Illinois, United States, 60515
United States, Michigan
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States, 48604
United States, Minnesota
Minnesota Gynecology and Surgery
Edina, Minnesota, United States, 55435
United States, New Mexico
Bosque Women's Care
Albuquerque, New Mexico, United States, 87109
United States, North Carolina
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Seven Hills Women's Center
Cincinnati, Ohio, United States, 45238
Amy Brenner MD & Associates, LLC
West Chester, Ohio, United States, 45069
United States, Tennessee
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States, 37404
Tennessee Women's Care
Nashville, Tennessee, United States, 37203
United States, Washington
Rockwood Clinic, P.S.
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Hologic, Inc.
Investigators
Layout table for investigator information
Study Director: Edward Evantash, MD Hologic, Inc.
Additional Information:
Publications:
Saunders, D: Essure and Endometrial Ablation: Clinical studies and case reviews of Essure with 118 NovaSure procedures, Supplement to OBG Management, April, 2010.

Layout table for additonal information
Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01934244    
Other Study ID Numbers: S0112003
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances