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Journal of Minimally Invasive Gynecology, Vol 12, No 5, September/October Supplement 2005
metallic implant remains fully outside the uterine cavity, advantages over other systems may include easier insertion and future access to intracavitary diagnostic or therapeutic interventions should they become necessary, possibly including IVF. Patient follow-up is ongoing. FRIDAY, NOVEMBER 11, 2005 (10:40 AM–10:50 AM) Plenary 10 —Hysteroscopy 96 Placement of a Transcervical Tubal Occlusion Device Through A 3.5-mm O.D. Flexible Hysteroscope Robles R, Isaacson KB. Guatemala City, Guatemala; Newton Wellesley Hospital, West Newton, Massachusetts Study Objective: To assess the feasibility, safety and efficacy of placing a new sub 3F transcervical tubal occlusion device (Eclipse, Ovion Inc). Design: Multicenter, single-arm feasibility study. Setting: Private hospital and private office setting in Mexico City, Mexico and Guatemala City, Guatemala. Patients: Patients in the reproductive age scheduled to undergo a hysterectomy for benign uterine conditions unrelated to the investigational device and who provided informed consent were recruited for placement of the Eclipse device 10 –12 weeks prior to hysterectomy. Intervention: Based on surgeon’s preference, the Eclipse transcervical tubal occlusion device was placed either with the 3.5 mm O.D. flexible hysteroscope (Karl Storz Endoscopy) or the 5.5 mm O.D. rigid hystersocope. Measurements and Main Results: Of 30 patients recruited for the study, 15 patients had the Eclipse device placed with the flexible hysteroscope. Of these, 14/15 had the device placed without the need for I.V., oral or local anesthesia. No tenaculum was used in these patients. The tubal occlusion data from the hysterectomy will be presented. Conclusion: The Eclipse transcervical tubal sterilization device can be successfully placed in the office or hospital setting using a 3.5 mm flexible hysteroscope and no anesthesia. FRIDAY, NOVEMBER 11, 2005 (10:50 AM–11:00 AM) Plenary 10 —Hysteroscopy 97 Office Hysteroscopic Sterilization Compared to Laparoscopic Sterilization: A Critical Cost Analysis Levie MD, Chudnoff S. Montefiore Hospital, Teaneck, New Jersey; Bronx, New York Study Objective: To evaluate the actual cost difference in performing an Essure hysteroscopic sterilization in the office compared to an ambulatory surgery using laparoscopic sterilization in the operating room. Design: Cost-comparison analysis. Setting: University hospital and affiliated out-patient office.
Patients: This is a cost-comparison of the typical costs to the healthcare economy at our institute, and does not involve individual patient data. Intervention: Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. Measurements and Main Results: The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We utilized actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost $3405 compared to hysteroscopic placement of the Essure device that costs $1374 yielding a $2031 difference between the procedures. Conclusion: In our institution and in our experience, officehysteroscopic placement of the Essure device is a more cost effective method than laparoscopic tubal ligation. FRIDAY, NOVEMBER 11, 2005 (11:00 AM–11:10 AM) Plenary 10 —Hysteroscopy 98 Hysteroscopic Sterilization: Long-Term Safety and Efficacy Kerin JF. Flinders University, Bedford Park, Adelaide, South Australia Study Objective: To assess the long term safety and efficacy of hysteroscopic sterilization. Design: The dynamically expanding Essure micro-insert (Conceptus Inc, San Carlos) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Setting: Hospital-based clinical trial. Patients: Successful bilateral micro-insert placement was achieved in 643 women. Intervention: After confirmation of tubal occlusion by hysterosalpingogram they began relying on the micro-inserts for contraception. These women were assessed at 1, 2, 3, 4 and 5-year intervals. Measurements and Main Results: As of December 16, 2004, 643 women contributed effectivness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29,357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase 11 subjects and 42.5 months for women in the Pivotal trial. To date there have been no long term adverse events that were concluded by the investigators to be directly related to the micro-insert placement procedure. Conclusion: These findings indicate that this non-incisional method of hysteroscopic sterilization can be performed without general anesthesia, and has acceptable long term safety and contraceptive efficacy.
Journal of Minimally Invasive Gynecology, Vol 12, No 5, September/October Supplement 2005
metallic implant remains fully outside the uterine cavity, advantages over other systems may include easier insertion and future access to intracavitary diagnostic or therapeutic interventions should they become necessary, possibly including IVF. Patient follow-up is ongoing. FRIDAY, NOVEMBER 11, 2005 (10:40 AM–10:50 AM) Plenary 10 —Hysteroscopy 96 Placement of a Transcervical Tubal Occlusion Device Through A 3.5-mm O.D. Flexible Hysteroscope Robles R, Isaacson KB. Guatemala City, Guatemala; Newton Wellesley Hospital, West Newton, Massachusetts Study Objective: To assess the feasibility, safety and efficacy of placing a new sub 3F transcervical tubal occlusion device (Eclipse, Ovion Inc). Design: Multicenter, single-arm feasibility study. Setting: Private hospital and private office setting in Mexico City, Mexico and Guatemala City, Guatemala. Patients: Patients in the reproductive age scheduled to undergo a hysterectomy for benign uterine conditions unrelated to the investigational device and who provided informed consent were recruited for placement of the Eclipse device 10 –12 weeks prior to hysterectomy. Intervention: Based on surgeon’s preference, the Eclipse transcervical tubal occlusion device was placed either with the 3.5 mm O.D. flexible hysteroscope (Karl Storz Endoscopy) or the 5.5 mm O.D. rigid hystersocope. Measurements and Main Results: Of 30 patients recruited for the study, 15 patients had the Eclipse device placed with the flexible hysteroscope. Of these, 14/15 had the device placed without the need for I.V., oral or local anesthesia. No tenaculum was used in these patients. The tubal occlusion data from the hysterectomy will be presented. Conclusion: The Eclipse transcervical tubal sterilization device can be successfully placed in the office or hospital setting using a 3.5 mm flexible hysteroscope and no anesthesia. FRIDAY, NOVEMBER 11, 2005 (10:50 AM–11:00 AM) Plenary 10 —Hysteroscopy 97 Office Hysteroscopic Sterilization Compared to Laparoscopic Sterilization: A Critical Cost Analysis Levie MD, Chudnoff S. Montefiore Hospital, Teaneck, New Jersey; Bronx, New York Study Objective: To evaluate the actual cost difference in performing an Essure hysteroscopic sterilization in the office compared to an ambulatory surgery using laparoscopic sterilization in the operating room. Design: Cost-comparison analysis. Setting: University hospital and affiliated out-patient office.
Patients: This is a cost-comparison of the typical costs to the healthcare economy at our institute, and does not involve individual patient data. Intervention: Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. Measurements and Main Results: The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We utilized actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost $3405 compared to hysteroscopic placement of the Essure device that costs $1374 yielding a $2031 difference between the procedures. Conclusion: In our institution and in our experience, officehysteroscopic placement of the Essure device is a more cost effective method than laparoscopic tubal ligation. FRIDAY, NOVEMBER 11, 2005 (11:00 AM–11:10 AM) Plenary 10 —Hysteroscopy 98 Hysteroscopic Sterilization: Long-Term Safety and Efficacy Kerin JF. Flinders University, Bedford Park, Adelaide, South Australia Study Objective: To assess the long term safety and efficacy of hysteroscopic sterilization. Design: The dynamically expanding Essure micro-insert (Conceptus Inc, San Carlos) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Setting: Hospital-based clinical trial. Patients: Successful bilateral micro-insert placement was achieved in 643 women. Intervention: After confirmation of tubal occlusion by hysterosalpingogram they began relying on the micro-inserts for contraception. These women were assessed at 1, 2, 3, 4 and 5-year intervals. Measurements and Main Results: As of December 16, 2004, 643 women contributed effectivness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29,357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase 11 subjects and 42.5 months for women in the Pivotal trial. To date there have been no long term adverse events that were concluded by the investigators to be directly related to the micro-insert placement procedure. Conclusion: These findings indicate that this non-incisional method of hysteroscopic sterilization can be performed without general anesthesia, and has acceptable long term safety and contraceptive efficacy.