Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Contraception Clinical Trial

Official title:

A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01948882
• Other study ID #: 16973
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2013
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 660
• Est. completion date: September 30, 2024
• Est. primary completion date: September 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 44 Years

Eligibility

Inclusion Criteria:

• Female, 21 to 44 years of age, inclusive
• Body weight within range of 90-300 lbs (40 - 136 kg)
• Sexually active (minimum of 4 coital acts per cycle)
• Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
• Medical history indicates bilateral viable and patent fallopian tubes
• Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods

Exclusion Criteria:

• Post-menopausal woman
• Suspected or confirmed pregnancy
• Post-partum or pregnancy termination =6 weeks of scheduled insert placement
• Past fallopian tube sterilization procedure and/or total or partial salpingectomies
• Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
• Currently taking corticosteroids
• Known allergy to all contrast media available for use in hysterosalpingogram
• Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
• Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• ESS505 (BAY1454033)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception	Evaluated after 6000 women-months of reliance have been accumulated	1 year
Primary	Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted	Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)	3 months
Secondary	Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception		10 years
Secondary	Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube		On day of placement procedure
Secondary	Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed		Up to 10 years

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards