check_circleStudy Completed

Contraception, Menorrhagia

Bayer Identifier:

16975

ClinicalTrials.gov Identifier:

NCT01740687

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test

Trial purpose

The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.

Key Participants Requirements

Sex

Female

Age

21 - 50 Years
  • - All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply.
    - Women experiencing menorrhagia due to benign causes
    - Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study)
    - Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia
  • - All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
    - Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
    - Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:
     -- Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed vaginal bleeding, endometrial cancer, myomas, and polyps)
     -- Reproductive tract anatomical variants and/or pathology which could make the subject unsuitable for the Essure and/or NovaSure transcervical procedures
    - Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure

Trial summary

Enrollment Goal
211
Trial Dates
November 2012 - June 2021
Phase
N/A
Could I Receive a placebo
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pottstown, 19464, United States
Completed
Nashville, 37232, United States
Withdrawn
Columbus, 43214, United States
Completed
Newburgh, 47630, United States
Withdrawn
Phoenix, 85015, United States
Completed
Easton, 21601, United States
Withdrawn
Winston-Salem, 27103, United States
Withdrawn
Denver, 80220, United States
Completed
Decatur, 62526, United States
Completed
Fort Wayne, 46825, United States
Completed
Spokane, 99204, United States
Completed
Grand Blanc, 48439, United States
Completed
Las Vegas, 89102, United States
Withdrawn
Nashville, 37232, United States
Withdrawn
Columbus, 43231, United States
Completed
Aurora, 80045, United States
Withdrawn
Dayton, 45409, United States
Completed
Ocala, 34471, United States
Completed
Winston-Salem, 27103, United States
Completed
Mason, 45040, United States
Completed
Maplewood, 55109, United States
Completed
Newburgh, 47630, United States
Completed
Englewood, 45322, United States
Completed
Norfolk, 23507, United States
Completed
Neptune, 07753, United States

Primary Outcome

  • Number of pregnancies at 1-year time point (1-year pregnancy rate)
    date_rangeTime Frame:
    1 year after NovaSure Endometrial Ablation procedure
  • Number of pregnancies at 3-year time point (3-year pregnancy rate)
    date_rangeTime Frame:
    3 years after NovaSure Endometrial Ablation procedure

Secondary Outcome

  • Number of adverse events (AEs) when NovaSure endometrial ablation was performed in the presence of Essure inserts
    An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.
    date_rangeTime Frame:
    After 3-year follow-up

Trial design

A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Trial Type
Observational
Intervention Type
Device
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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