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.
Brief Title
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Detailed Description
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Contraception
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
* 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
Inclusion 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)
* 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)
Gender
Female
Gender Based
false
Keywords
Birth control
Permanent Contraception
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
44 Years
Minimum Age
21 Years
NCT Id
NCT01861886
Org Class
Industry
Org Full Name
Bayer
Org Study Id
16972
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Outcome Time Frame
3 months
Secondary Ids
Secondary Id
ESS505-003
Secondary Outcomes
Outcome Time Frame
12 months
Outcome Measure
Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
Outcome Description
Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.
Outcome Time Frame
3 months
Outcome Measure
Frequency (number) of reported ESS505 placement procedure-related AEs
Outcome Description
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Outcome Time Frame
3 months
Outcome Measure
Severity of reported ESS505 placement procedure-related AEs
Outcome Description
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Outcome Time Frame
3 months
Outcome Measure
Frequency (number) of reported ESS505 (device) wearing-related AEs
Outcome Description
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Outcome Time Frame
3 months
Outcome Measure
Severity of reported ESS505 wearing-related AEs
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
44
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Levie
Investigator Email
malevie@montefiore.org