OBJECTIVE: Small bowel pathology can be diagnosed using enteroscopy (which has limitations) and by x-ray (which is not sensitive for flat lesions). For the first time ever, we used a new technique, wireless-capsule video endoscopy, to diagnose small bowel pathology. Our aim was to prove the effectiveness and safety of this technology. METHODS: We used the Given (M2A) system in 35 patients, aged 18-80 yr, who suffered from unexplained GI bleeding or in whom there was a clinical suspicion of small bowel disease. All patients had a small bowel x-ray. Patients with suspected narrowing of the bowel or a clinical suspicion of intestinal obstruction, or with a history of major abdominal surgery, were excluded from the study. No pregnant women or patients with diabetes mellitus were included. RESULTS: Abnormal findings were found in 29 of 35 (82.9%) patients. Twenty-two of 29 (75.9%) patients had significant pathological findings explaining their clinical situation. Diagnostic yield was therefore 62.9% (22 of 35 patients). Among the various findings, the capsule detected ulcers, erosions, angiodysplasia, and submucosal lesions. The source of bleeding was found in 15 of 20 patients with iron deficiency anemia. There were no immediate significant side effects and none reported up to 1 month after ingestion of the capsule. The capsule was evacuated by all patients. CONCLUSIONS: The wireless-capsule video endoscope, in our study of feasibility, was proven to be a safe, painless, ambulatory, and effective procedure, with a high diagnostic yield. Its major importance is in diagnosing small bowel pathology where all other imaging techniques have failed.