ESS-NSPAS: A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01740687
• Collaborator: (none)
• Enrollment: 209
• Locations: 17
• Actual Duration (Months): 103
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Menorrhagia	Device: ESS305 (Essure, BAY1454032); Procedure: NovaSure

Detailed Description

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Study Design

• Study Type: Observational
• Actual Enrollment: 209 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
• Actual Study Start Date: Nov 13, 2012
• Actual Primary Completion Date: May 17, 2021
• Actual Study Completion Date: Jun 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Essure+NovaSure The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test	Device: ESS305 (Essure, BAY1454032); Essure Permanent Birth Control; Procedure: NovaSure; Nova Sure Endometrial Ablation

Outcome Measures

Primary Outcome Measures

1. 1-Year Pregnancy Rate [1 year after NovaSure Endometrial Ablation procedure]

2. 3-Year Pregnancy Rate [3 years after NovaSure Endometrial Ablation procedure]

Secondary Outcome Measures

1. Incidence of Adverse Events when Novasure endometrial ablation is performed in the presence of Essure inserts [After 3-year follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Aurora	Colorado	United States	80045
2		Ocala	Florida	United States	34471
3		Decatur	Illinois	United States	62526
4		Fort Wayne	Indiana	United States	46825
5		Newburgh	Indiana	United States	47630
6		Easton	Maryland	United States	21601
7		Grand Blanc	Michigan	United States	48439
8		Maplewood	Minnesota	United States	55109
9		Las Vegas	Nevada	United States	89102
10		Neptune	New Jersey	United States	07753
11		Winston-Salem	North Carolina	United States	27103
12		Englewood	Ohio	United States	45322
13		Mason	Ohio	United States	45040
14		Pottstown	Pennsylvania	United States	19464
15		Nashville	Tennessee	United States	37232
16		Norfolk	Virginia	United States	23507
17		Spokane	Washington	United States	99204

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01740687
• Other Study ID Numbers: 16975
• First Posted: Dec 4, 2012
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Endometrial Ablation; Permanent Sterilization; Essure; NovaSure; Prevention of Pregnancy
• Additional relevant MeSH terms: Menorrhagia

Study Results

No Results Posted as of Jun 23, 2021