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Procedure May Make Office Sterilization Possible.

CHICAGO -- A novel method of occluding fallopian tubes may someday make sterilization an office-based procedure, Dennis R. Stewart, Ph.D., said during the annual meeting of the American College of Obstetricians and Gynecologists.

The investigational procedure, which was developed by researchers at Adiana Inc. of Redwood City, Calif., involves the transcervical placement of a synthetic matrix material into each of the fallopian tubes.

Before the matrix is placed, a bipolar radio frequency generator that's connected to a catheter delivers energy to ablate the lining of each fallopian tube. This procedure is designed to stimulate ingrowth of tissue into the matrix material, explained Dr. Stewart, who is employed by Adiana.

Unlike conventional sterilization, which involves an incision and requires anesthesia, the entire Adiana procedure can be done transcervically through a hysteroscope, he added.

In a pilot study, four patient volunteers underwent the Adiana procedure 12 weeks before an elective hysterectomy for abnormal bleeding.

Hysterosalpingography was performed on each of the patients before the matrix was placed in order to confirm tubal patency.

Twelve weeks after the matrix had been placed, a second hysterosalpingography showed that all treated tubes were blocked.

The scheduled hysterectomy was then performed.

After the hysterectomy, researchers evaluated tubal occlusion in a series of in vitro experiments on the retrieved fallopian tube specimens. Under pressure testing, none of the tubal occlusions leaked at 50 mm Hg; one leaked at 100 mm Hg, and a second tube leaked at 150 mm Hg.

Histologic analysis of the occlusions confirmed the ingrowth of tissue into the matrix.

Fibroblasts, blood vessels, extracellular matrix, and inflammatory cells were all found in the material. The inflammatory response was judged to be only mild to moderate.

This finding indicated the potential for long-term acceptance of the matrix, Dr. Stewart said.

All patients were sedated during the procedure and tolerated it well; none of the study participants reported any associated pain.

Adiana plans to initiate a study next year to gather data for Food and Drug Administration approval, Dr. Stewart added in an interview.
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Publication:OB GYN News
Date:Jul 1, 2001
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