9% bilateral placement rating.1 Adiana selleck screening library Clinical Trial Figure 2 depicts the EASE trial for Adiana. In this study, 655 women underwent hysteroscopy. Ten women were excluded due to anatomic factors preventing visualization of tubal ostia, leaving 645 women undergoing attempted procedure. Of the women who underwent attempted procedure, successful bilateral treatment was achieved in 611 women (94.7%). As in the Essure trials, 7 women required a second procedure to achieve bilateral treatment and are included in the 611 women for analysis. Prior to 3-month HSG, 6 women were lost to follow-up, 1 woman became pregnant and was excluded from the study, and 604 women underwent a 3-month HSG. During the 3-month HSG, 551 women were found to have bilateral occlusion and 53 women were determined to have tubal patency.
Of the 53 women, 1 woman was lost to follow-up, 2 women became pregnant, 5 were not re-evaluated, and 45 underwent a 6-month HSG. Of these 45 women, 19 (42%) were found to have bilateral occlusion whereas 26 (58%) women remained patent. In all, 570 of 611 women (93.3%) with bilateral placement were instructed to rely on the Adiana procedure for pregnancy prevention. Interestingly, the study protocol included ultrasound evaluation of silicone implants at both 1 week and 3 months.2,7,11 However, the authors did not report data concerning the findings of these ultrasounds. Therefore, it is uncertain how many implants were identified at these time intervals. In the subsequent 5 years of data collection, 12 pregnancies have been documented.
In the first year of reliance, 1 woman experienced an ectopic pregnancy that was successfully treated with methotrexate and 5 women experienced intrauterine pregnancies. In the second year of reliance, 1 woman experienced an ectopic pregnancy requiring operative salpingectomy and 2 women experienced intrauterine pregnancies. No pregnancies were reported in year 3; 2 intrauterine pregnancies were reported in year 4 and 1 intrauterine pregnancy was reported in year 5. Not all women have completed the full 5-year follow-up, so additional data may be reported concerning outcome in these patients.2,7,11,12 Figure 2 Adiana? Permanent Contraception (Hologic, Inc., Bedford, MA) clinical trial (Evaluation of the Adiana System for Transcervical Sterilization [EASE] trial).2,7,11 *Seven patients required a second procedure to obtain successful bilateral placement.
… Comparison of Clinical Trial Data Although clinical trials for Essure and Adiana were well designed and appear to have been conducted in a similar fashion, analysis of data and, thus, reporting among the manufacturers are not always consistent. Essure and Adiana represent very distinct procedures due to their mechanism of action and postprocedural evaluation. As the Essure insert is Cilengitide visible on radiographic imaging, certain clinical decisions and actions can be made when a tubal patency is encountered.