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AltaSeal Hysteroscopic Sterilization: The New Challenger to Essure?

      Study Objective

      The effectiveness of existing hysteroscopic sterilization methods depend on the ingrowth of fibrous tissue. Although the methods seem to be very reliable, it is reported that as many as 50 to 89% of patients do not show up for HSG confirmation. The results of a study on a new experimental tubal occlusion implant device (AltaSeal, AltaScience Ltd.) not dependant on tissue ingrowth will be presented, suggesting that a confirmation test may not be necessary. Objective: A perihysterectomy pilot study, performed between August 2010 and January 2011 at the above mentioned institution evaluating the placement feasibility and tubal occlusion effectiveness of the implant.

      Design

      Non-randomised, single arm study of 10 patients (20 tubes) scheduled for a hysterectomy for benign pathology.

      Setting

      Large non-academic teaching hospital.

      Patients

      Premenopausal patients with an indication for hysterectomy for benign pathology, having consented to undergo a hysteroscopic sterilization immediately prior to the operation.

      Intervention

      Hysteroscopic sterilization with a new tubal occlusion device (Altaseal). Tubal patency was assessed through HSG prior to and immediately following implantation such that the performance of the implant in terms of tubal occlusion could clearly be identified. A further methylene blue leak test was performed post implantation.

      Measurements and Main Results

      Due to distortion of the cavity by fibroids no more than 9 tubes could be evaluated as being either patent or accessible, of these 8 were closed by the device (89%). One tube remained patent due to incorrect placement of the device in relation to the tubal orifice. As a result of this case the design was updated to prevent such an occurence.

      Conclusion

      Following the success of this pilot study a further study to prove the reliability of the device has been designed and is awaiting approval of the ethics committees. If the results meet the expectations, this new device may have immediate reliablity without the need for a confirmation test.