The STOP Device

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Dr. Mark Smith: "Good morning again. Here we are, still at the 1999 AAGL meeting. We're very fortunate to have in the booth with us Dr. Jay Cooper, who really needs no introduction for those of you who do endoscopy and hysteroscopy. He's one of the pioneers of a lot of the innovative hysteroscopic techniques that have been used over the years. Today we want to ask him about some of the newer things and one particular technique that's really going to be revolutionary about hysteroscopy. I think he's very excited about it, and a lot of people here are, too-Dr. Cooper?"

Dr. Jay Cooper: "Thanks, Mark. One of the most exciting procedures that has been discussed here at the meeting is the STOP sterilization device. This is a device that's placed into a woman's fallopian tube, but at the opening of the fallopian tube. We can identify the opening of her fallopian tube with hysteroscopy by inserting a telescope through the cervix into the uterine cavity. We see the opening of the fallopian tube and then advance a catheter with a specially-designed micro coil to occupy the proximal portion, the first 4-mm of her fallopian tube. Once we remove the catheter, the device then expands to as large as 2-mm in diameter and remains in place to affect sterilization."

Dr. Mark Smith: "Is this in the isthmic portion of the tube that you're talking about?"

Dr. Jay Cooper: "It's placed at the uterotubal junction, and that makes this technology unique. As you know, female sterilization is one of the most common procedures we all perform. Probably thirteen million women will have sterilization performed every year, and the great majority of these procedures are done making use of general anesthesia and laparoscopy. Of course, if you could have a procedure that could be done in an office setting, transcervical, and under hysteroscopic control, you'd really have something unique. I think many women who in their hearts would really like to have a sterilization but choose not to have it done do so because they reject the concept of traditional invasive, incisional surgery, and this would have great application for them."

Dr. Mark Smith: "So this is an office procedure?"

Dr. Jay Cooper: "It certainly is an office procedure in our offices in Phoenix. You have to understand, we've completed Phase II clinical evaluation. The company that manufactures this device, Conceptus, Inc., in California, has petitioned the FDA to expand the clinical study to as many as four hundred women. The procedures will be performed in Australia, Europe, and in the United States."

Dr. Mark Smith: "What type of discomfort do the women have with this? Is it like a typical office hysteroscopy?"

Dr. Jay Cooper: "It's really remarkable how little discomfort women have. All of our procedures have been done in the office. We've performed what we call 'paracervical block' to administer some local anesthetic around the cervix. In some cases, we've given women some intravenous medication to give them some mild anxiety relief, but the great majority of the women have little or no discomfort when we place these devices."

Dr. Mark Smith: "Great. Now, obviously you're in the developmental stages of it. For several years I know other types of mechanical barriers have been tried. I'm assuming the results with this are very good, at this point?"

Dr. Jay Cooper: "Yes. We have eighty-eight women enrolled in the clinical study to this point, and forty-nine of these women have reached the three-month point in follow-up. These women have all had x-rays taken to be sure that these devices are properly positioned and that no dye that we put into the uterus passes the tubes. That assures us that the devices are occlusive, and they're going to achieve long-term contraception, and the results have been excellent. We do not have a single pregnancy, and we have well over three hundred women over months of wearing data, so we're very excited."

Dr. Mark Smith: "Great."

Dr. Jay Cooper: "It's a good time."

Dr. Mark Smith: "Everything fails occasionally, but sitting there with no pregnancies at this point is certainly encouraging."

Dr. Jay Cooper: "It's a good beginning."

Dr. Mark Smith: "You had a picture-do you want to just show it so the people will understand a little bit of the mechanism?"

Dr. Jay Cooper: "Yes. What you have here is a diagrammatic representation of a hysteroscope placed in the uterus. We're using a saline distension medium to distend the uterus so we can see this area right here-this is the ostium tube. We're able to advance the catheter into the fallopian tube as much as 4 mm, and then we withdraw the catheter, which allows this device to go from a wound-down state, almost like a slinky. Remember when you were a kid, and you played with a slinky? This is first a wound-down slinky, and then when we release it, it is able to expand to as much as 2 mm in diameter and that achieves…"

Dr. Mark Smith: "And that provides occlusion by its expansion...?"

Dr. Jay Cooper: "Interestingly enough, this device actually has a Dacron mesh which runs the entire length of the device. What that does is it excites a tissue reaction of a benign tissue action that incorporates this device into the fallopian tube and illuminates the normal tubal architecture. So the combination of space occupying of the device and this tissue reaction, this scarification, achieves sterilization."

Dr. Mark Smith: "It sounds promising."

Dr. Jay Cooper: "Yes."

Dr. Mark Smith: "And I can tell that you're excited about it."

Dr. Jay Cooper: "I'll come back and talk with you next year."

Dr. Mark Smith: "Get some more data-we'll look forward to it."

Dr. Jay Cooper: "Thanks."

Dr. Mark Smith: "Thanks very much, Jay, for joining us today."

Dr. Jay Cooper: "Thanks, Mark."