Background and Study Aims: Double-balloon enteroscopy (DBE) is a new endoscopic method for examining the small intestine. Most reports of DBE have been from Japan, and very few data on this new technique have been reported by centers outside Japan. The aim of the present study was to determine the diagnostic yield of DBE, measure the frequency of management changes made on the basis of the results, and evaluate the clinical outcome for patients undergoing the procedure. Patients and Methods: All patients undergoing DBE using a Fujinon enteroscope (length 200 cm, diameter 8 mm) during a 11-month period were studied. All of the patients had previously undergone esophagogastroduodenoscopy and colonoscopy. They underwent small-bowel cleansing on the day before the procedure using a standard colon lavage solution. Results: Seventy DBE procedures were carried out in 53 patients (34 men, 19 women; mean age 60 years, range 24 - 80) by the oral route in 46 cases and the anal route in 24. The indications for the examination were gastrointestinal bleeding (n = 29), suspected Crohn’s disease (n = 6), abdominal pain (n = 4), polyp removal or evaluation in polyposis syndromes (n = 6), chronic diarrhea (n = 4), and surveillance or tumor search (n = 4). The mean duration of the procedure was 72 min (range 25 min - 3 h). The mean radiation exposure was 441 dGy/cm (range 70 - 1462), and the mean depth of small-bowel insertion was 150 cm (range 1 - 470 cm). It was possible to evaluate the entire small bowel in four patients (8 %). A new diagnosis was obtained in 26 of the 53 patients (49 %). The findings in the 70 procedures were angiodysplasia (n = 13), ulcerations or erosions (n = 5), jejunitis or ileitis (n = 5), tumors (n = 5), stenosis (n = 4), polyps (n = 5), lymphangiectasias (n = 4), Crohn’s disease (n = 4), and normal (n = 17). DBE resulted in a therapeutic intervention (endoscopic, medical or surgical, excluding blood transfusions) in 57 % of the patients (30 of 53). The only complication (1.4 %) observed was one case of intraprocedural postpolypectomy bleeding, which resolved with injection of epinephrine. Conclusion: In almost two-thirds of the patients examined, DBE was clinically useful for obtaining a new diagnosis and starting new treatments, changing existing treatments, carrying out surgical intervention, or providing therapeutic endoscopy. DBE is a useful and safe method of obtaining tissue for diagnosis, providing hemostasis, and carrying out polypectomy.