New Sterilization Procedure Can Be Done Without Abdominal Incision
May 1, 2001 (Chicago) -- Researchers from a small medical device company in California say they will begin pivotal trials within a year of a new sterilization procedure that will allow women to be sterilized during a 20-minute procedure in a doctor's office -- with no surgical incision into the abdomen.
Researcher Dennis R. Stewart, PhD, presented findings from a very small pilot study of the procedure at the American College of Obstetricians and Gynecologists meeting held here.
Stewart tells WebMD that it takes about 10 minutes to perform the procedure on each fallopian tube. The doctor first places a flexible tube-like device called a hysteroscope through the vagina and through the cervix into a woman's uterus. A smaller tube called a catheter is threaded through the scope into the fallopian tube. The catheter has an electrode on its tip that the doctor uses to cause a small injury to the inner lining of the fallopian tube. Then the doctor deposits a tiny honeycomb-like matrix of silicon into the fallopian tube. The procedure is then repeated in the other fallopian tube.
Stewart says the injury to the lining causes the growth of scar tissue, which then grows into the silicon matrix until it completely blocks the tube. Once the tube is completely blocked, the egg cannot pass from the ovary, down the tube, and into the uterus.
The research company, based in Redwood City, Calif., is called Adiana Inc., and the sterilization process is called the Adiana method. At the meeting, Stewart reported on four women who volunteered to have the procedure before undergoing voluntary hysterectomy. The women underwent Adiana sterilization 12 weeks before hysterectomy and the tubes were removed at the time of the hysterectomy.
Stewart says that it is unknown if total blockage "could take less than 12 weeks. Right now we are saying 12 weeks and during that time the woman would need to use another type of contraception."
When the tubes were removed, visual examination revealed that all tubes were completely blocked, says Stewart. Stewart says the effectiveness of the process was also tested by injecting dye into the tubes after removal. The dye was infused under varying pressures but the tubes "didn't leak until the dye was infused at a pressure five times the normal pressure within the tube."
Adam Savakus, vice president of regulatory and clinical affairs at Adiana, tells WebMD that pivotal human trials are expected to begin in the U.S. by the end of 2002. "We already have about 30 women who have participated in safety studies," he says.
Stewart says that all the safety studies are done in women who are scheduled for hysterectomy. "The pivotal studies will be a trial of the procedure for elective sterilization," he says.