Using the EDAP LT-01 piezoelectric lithotriptor (EDAP International, Boston, Massachusetts) and adjuvant ursodiol therapy we treated 60 patients who had symptomatic cholelithiasis. No anesthesia, analgesia, or sedation was required for any patient. Patients were followed for as long as 18 months (mean, 8.5 months) from the time of their first treatment. Complete stone clearance occurred in 62% of patients followed for 9 months. When analyzed by stone size, the 9-month stone-free rate was 75% in patients with a solitary stone of 20 mm or less in diameter and 57% in patients with two or three stones. The 7 patients who had gallstones more than 20 mm in diameter are not yet stone free. No patient developed significant clinical complications or laboratory abnormalities after lithotripsy. Mild to moderate biliary pain occurred after lithotripsy in 83% of the patients. Five patients had elective cholecystectomy for persistent colic. One patient developed mild, self-limited pancreatitis. Our results with the EDAP LT-01 piezoelectric lithotriptor are encouraging. Treatment can be carried out safely in the outpatient setting and without the need for anesthesia, analgesia, or sedation.