Universal Axon Clinical Research, LLC | Doral, FL
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This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:
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Inclusion criteria
Subjects who are at least 21 years of age;
Subjects of all weights will be included;
Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
For the Essure group only:
• Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;
For the laparoscopic tubal sterilization group only:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
990 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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