To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
134
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Colorado Springs, Colorado, United States
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Time frame: Day 1
Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
Time frame: Day 1
Evaluation of investigator questionnaire regarding ESS310 design and usability
Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
Time frame: Day 1
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
Time frame: Day 1
Hysteroscopy time to perform the procedure
Time frame: Day 1
Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
Time frame: 1 week
Number of participants with Adverse procedure-related events as a measure of safety and tolerability
Time frame: Day 1, 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Fort Wayne, Indiana, United States
Unnamed facility
Newburgh, Indiana, United States
Unnamed facility
Grand Blanc, Michigan, United States
Unnamed facility
Saginaw, Michigan, United States
Wayne State University Physicians Group
Southfield, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
...and 6 more locations