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Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

2017-04-26 09:08:22 | BioPortfolio

Summary

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

Study Design

Conditions

Contraception

Intervention

Blood draw, ESSURE (BAY1454032), Laparoscopic tubal sterilization

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-04-26T09:08:22-0400

Clinical Trials [1697 Associated Clinical Trials listed on BioPortfolio]

Retrospective Claims Analysis of Hysterectomy After Sterilization

The research questions are: 1. What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation? 2. What is the pro...

Proportion of Hysterectomy After Female Sterilization

The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had unde...

FemBloc® Contraception Pivotal Trial

Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group tot...

Observational Study on Contraception With Essure in France

The aim of the SUCCES II study is to describe the use and characteristics of definitive contraception with Essure. The study will be conducted in real-life conditions and will allow descr...

Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization

More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking wome...

PubMed Articles [7561 Associated PubMed Articles listed on BioPortfolio]

Adverse Events Attributed to the Sterilization Method Essure: Failure to Demonstrate a Causal Association With Nickel Sensitization.

Essure is an effective method for hysteroscopic sterilization. Reports of adverse effects, the underlying mechanisms of which are unknown, have increased in recent years.

Laparoscopic Management of 42 Cases of Tubal Stump Pregnancy and Postoperative Reproductive Outcomes.

Tubal stump pregnancy is a rare variant of ectopic pregnancy. The aim of this study was to evaluate laparoscopic surgery for tubal stump pregnancy and investigate postoperative pregnancy outcomes.

Laparoscopic Essure device removal by en bloc salpingectomy-cornuectomy with intraoperative X-ray checking: a retrospective cohort study.

The aim of this study was to evaluate the feasibility, efficacy, and morbidity of Essure device removal via laparoscopic en bloc salpingectomy-cornuectomy resection (LSC) and the utility of confirmati...

Retained Essure Implants After Salpingectomy and Essure Removal Procedure.

Expedited Scheduling of Interval Tubal Ligation: A Randomized Controlled Trial.

To assess whether expedited scheduling for permanent contraception increases the proportion of patients completing interval tubal ligation within 6 months of delivery.

Medical and Biotech [MESH] Definitions

Prevention of CONCEPTION by blocking fertility temporarily, or permanently (STERILIZATION, REPRODUCTIVE). Common means of reversible contraception include NATURAL FAMILY PLANNING METHODS; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.

Procedures that render the female sterile by interrupting the flow in the FALLOPIAN TUBE. These procedures generally are surgical, and may also use chemicals or physical means.

Procedures to block or remove all or part of the genital tract for the purpose of rendering individuals sterile, incapable of reproduction. Surgical sterilization procedures are the most commonly used. There are also sterilization procedures involving chemical or physical means.

The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.

Reproductive sterilization without the consent of the patient.

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