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Post Approval NovaSure Essure Labeling Study

NCT01934244 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 318

Last updated 2018-07-30

No results posted yet for this study

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.

Conditions

  • Menorrhagia

Interventions

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.

Sponsors & Collaborators

  • Hologic, Inc.

    lead INDUSTRY

Principal Investigators

  • Edward Evantash, MD · Hologic, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2018-10-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01934244 on ClinicalTrials.gov