Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Status: | Recruiting |
---|---|
Conditions: | Contraception, Contraception |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 3/28/2019 |
Start Date: | May 3, 2017 |
End Date: | December 31, 2024 |
Contact: | Bayer Clinical Trials Contact |
Email: | clinical-trials-contact@bayer.com |
Phone: | (+) 1-888-8422937 |
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
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
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
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:
- 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.
We found this trial at
63
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
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Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1969 W Ogden Ave
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 864-6000
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John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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