Trial Condition(s):
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
16972
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To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.
- 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)
- 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
Locations | |
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Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOFDDORP, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIEUWEGEIN, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tiel, Netherlands, 4002 WP | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Prevention
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1