A prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a new lesion localization device

Background: The objective was to compare the safety and effectiveness of a new localization device to traditional flexible wires. Safety variables included blood loss, procedure time, pain and complications. Effectiveness variables included placement accuracy, lesion retrieval, histological diagnosis, procedural enhancements, and margin status. Methods: Twelve sites enrolled 120 patients between June 2000 and June 2001, with 58 randomized to treatment and 62 to control. Results: The two groups were equivalent in device placement accuracy, lesion retrieval, histological diagnosis, blood loss, pain, and complications. There was a significant difference favoring the treatment group for procedural enhancements, (ie, use as a palpable guide and retractor) and operating time. There were significantly fewer positive margins in the treatment group. Conclusions: This multicenter trial demonstrated equivalent safety and improved effectiveness for the treatment group. The new device demonstrated greater surgeon utility, reduced operative time, and fewer positive margins than the current wires.