N/A
Completed N=211
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Contraception · Menorrhagia
Source: ClinicalTrials.gov NCT01740687 ↗
Enrolled (actual)
211
Serious AEs
8.5%
Results posted
Feb 2023
Primary outcomePrimary: Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate) — 0 Pregnancy
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate) |
— | — |
| PRIMARY Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate) |
— | — |
| SECONDARY Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts |
398; 28 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01740687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.