Conceptus - Phase II Clinical Trials

Article Conference CoverageFrom American Association of Gynecological LaparoscopistsOrlando, Florida, November 2000


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Dr. Mark Smith:  “Good morning, we’re honored to have with us here today, Dr. Jay Cooper, a good friend of mine but more importantly the new incoming President of the AAGL.  First of all, congratulations.”

Dr. Jay Cooper:  “Thank you.“

Dr. Mark Smith:  “Jay’s also interviewed with us last year.  He and I were laughing about watching our old interview about a new program that he’s one of the principle investigators in with Conceptus.  Jay, I’d like an update and see what’s progressed since we interviewed you last year.”

Dr. Jay Cooper:  “A lot has happened.”

Dr. Mark Smith:  “With you there usually is.”

Dr. Jay Cooper:  “Thanks, and all good things.  The clinical trials are moving along very well.  We completed the Phase II clinical trial and well over 200 women had the procedure performed.  Our results have been very encouraging.  We’re now involved in the Phase III or pivotal trial in which 400 women will have this procedure performed, and after they wear the devices for a year’s period of time, the company will report it’s status to the FDA and, hopefully, achieve approval so that every doctor - even you Mark - will be able to do this procedure.”

Dr. Mark Smith:  “Good, I followed you around a lot Jay over the years if you recall.  I guess you’re not able to give us any estimated time yet.”

Dr. Jay Cooper:  “It’s hard to say when this technology will be available, so much depends on regulatory issues but when you realize that 800,000 women every year in this country undergo incisional sterilization, primarily laparoscopic tubal ligation…”

Dr. Mark Smith:  “Under general anesthesia.”

Dr. Jay Cooper:  “Under general anesthesia requiring an abdominal incision, at least one, sometimes more than one, you begin to perceive the potential for a procedure that is, we can’t say it’s non-surgical but we can certainly say it’s minimally invasive and we can say that it is non-incisional, and it doesn’t require general anesthesia.  I think women for the most part who consider sterilization sort of hold back because of their concern about the risks and the discomfort associated with traditional sterilization.”

Dr. Mark Smith:  “I agree.”

Dr. Jay Cooper:  “And this STOP device, this permanent contraceptive device, I think offers women an alternative.  That’s been our experience.”

Dr. Mark Smith:  “Good, it sounds like it’s very encouraging.  You confided earlier the failure rate is very, very good or bad meaning very low.”

Dr. Jay Cooper:  “With this device we’ve had no pregnancies and that’s tremendously encouraging.  As importantly, women who’ve had this procedure performed when we interview them a week afterwards tell us that they have no pain and they have no irregular bleeding.  Ninety-eight percent of women that have this procedure performed have no discomfort whatsoever after the week when we give them a call.  Now they may be totally comfortable forty-eight hours after but we don’t call them forty-eight hours after, we call them a week afterwards.  My experience has been that the procedure is extremely well tolerated, we perform this in an office setting, and we use a local anesthetic - a small amount of Novocain that we inject around the cervix.  Some of the patients request some IV medication for relaxation but we don’t put people to sleep so they’re able to watch the procedure on the video monitor and they’re able to have a dialogue.  Frankly, it’s an enjoyable experience.”

Dr. Mark Smith:  “Good, Jay, thanks for coming back with us.  We look forward to next year and maybe we can do it again, and who knows, maybe I’ll be using it by then.”

Dr. Jay Cooper:  “That would be great, Mark, thanks.”

Dr. Mark Smith:  “Thanks, Jay.”



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