A Phase 4 interventional study of TVU in Contraceptive Usage, sponsored by Bayer. Completed at 21 sites in 4 countries. Open to female participants aged 21 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts.
The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.
This study has previously been posted by Conceptus, Inc. (USA).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: TVU
Use of transvaginal ultrasound to determine location of micro-insert
Effectiveness
Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm
Time frame: Annually beginning at one year
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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