A Multicenter, Randomized, Controlled Study of the Breast Biopsy and Circumferential Excision System for Breast Lesions

Abstract

Background: This study aimed to verify the effectiveness, safety, and reliability of the breast biopsy and circumferential excision system.

Methods: It was designed as a multicenter, randomized, open-label, positive control, noninferiority trial. A total of 168 subjects who met the breast lesion screening requirements of the clinical trial protocol were randomly divided into a breast biopsy and circumferential excision dual cutting system test group or Mammotome control group. The main outcome was the successful removal rate of suspected lumps during surgery. Secondary outcomes included the operative times for individual lumps, weight of removed cord tissue, and several indicators of device performance. Safety indicators, including routine blood, blood biochemical and electrocardiogram examinations, were measured at baseline and 24 hours and 48 hours after the operation. Postoperative complications and combined medication use were observed and recorded until 7 days after the operation.

Results: The results showed no significant differences in efficacy and safety between the 2 groups (main efficacy, P = .7463; all secondary efficacy indicators, P > .05, except weight of removed cord tissue [P = .0070] and touch sensitivity of the device interface [P = .0275]; all safety indicators, P > .05). The results suggested that the test device is effective and is acceptable safe for use in breast lesion biopsy.

Conclusion: For patients with a high incidence of breast lesions, the results of this study provide a safe, effective, sensitive and accessible option for the removal of breast mass biopsies at a price much lower than that of imported devices.

Keywords: Benign breast tumor; Breast biopsy sample; Randomized controlled trial; Removal rate; Ultrasound guidance.