Clinical trial NCT01861886: The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Official title: A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Birth control
Permanent Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 73
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

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

Eligibility criteria: Inclusion Criteria:

* Female with age range 21 to 44 years
* Subjects who are seeking permanent contraception
* Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
* Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
* Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
* Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
* Subjects who provide written informed consent prior to enrolment
* Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
* Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
* Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)

Exclusion Criteria:

* Subjects with known proximal tubal occlusion in either fallopian tube
* Subjects who have undergone fallopian tube sterilization procedure
* Subjects diagnosed with unicornuate uterus
* Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
* Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
* Subjects suspected of being or confirmed pregnant
* Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
* Subjects diagnosed with active upper or lower pelvic infection
* Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
* Subjects have positive pre-procedure pregnancy test

Primary outcomes:
measure: Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
timeFrame: 3 months
Secondary outcomes:
measure: Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
timeFrame: 12 months
measure: Frequency (number) of reported ESS505 placement procedure-related AEs
timeFrame: 3 months
measure: Severity of reported ESS505 placement procedure-related AEs
timeFrame: 3 months
measure: Frequency (number) of reported ESS505 (device) wearing-related AEs
timeFrame: 3 months
measure: Severity of reported ESS505 wearing-related AEs
timeFrame: 3 months
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Tiel
country: Netherlands
city: Zwolle
country: Netherlands
city: Córdoba
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: