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An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post Procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Overall Recruitment Status: Active, enrollment completed
 
Official Title
An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post Procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
 
Region Sponsors
Mid-Atlantic
Bayer
 
Acronym KP IRB No.
MA-17-155
 
Study Type Phase
Clinical Trial Phase IV
 
Study Population Description
Contraception;
 
Purpose
This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including: Pelvic and/or lower abdominal pain Abnormal uterine bleeding Surgical intervention (including "insert removal" and hysterectomy) Allergic, hypersensitivity, or autoimmune-like reactions
 
Detailed Description
 
Gender Age Limit
Female 21 - 45 years
 
Inclusion Criteria
  • Subjects who are 21 to 45 years of age
  • Subjects who are between 90 and 300 pounds
  • 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: Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
 
Exclusion Criteria
  • Subjects who are post-menopausal
  • Subjects suspected of being or confirmed pregnant
  • Subjects post-partum or undergone pregnancy termination =6 weeks prior to scheduled procedure
  • Subjects uncertain about ending fertility
  • Subjects with an active upper or lower genital tract infection
  • Subjects with gynecologic malignancy (suspected or known)
  • Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic)
  • Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization
  • Subjects with unexplained vaginal bleeding

 
Keywords and/or Specific Medical Conditions
  • contraception
  • Obstetrics and Gynecology
 
KP Clinical Facility
  • Largo Medical Center
 
Clinical Area
  • Obstetrics and Gynecology


Principal Investigator:
Jill Finkelstein, MD
Contact Information:
- Leslie Greenberg, BA, MS, RN
-301-816-6768
-leslie.k.greenberg@kp.org
-Largo Medical Center


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