At a glance
ClinicalIndex Comparison RecordN/ACompleted· 211 enrolled
Drug / intervention
ESS305 (Essure, BAY1454032) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
In Brief
An observational study evaluating ESS305 (Essure, BAY1454032) and NovaSure for Contraception and Menorrhagia. Completed, enrolled 211 participants across 17 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsContraception, Menorrhagia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedDec 2012
Primary CompletionMay 2021
Study CompletionJun 2021
TodayJul 2026
First PostedDec 4, 2012
Enrollment StartNov 13, 2012
Primary CompletionMay 17, 2021
Study CompletionJun 14, 2021
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 13.6 years ago
Interventions
ESS305 (Essure, BAY1454032)device
Essure Permanent Birth Control
NovaSureprocedure
Nova Sure Endometrial Ablation