Comparative evaluation of SanAgileTMSA01 ultrasonic scalpel and Johnson & Johnson GEN11, and HAR36 for efficacy and safety.

Abstract

Background: The advent of ultrasonic scalpels has remarkably advanced minimally invasive surgery; however, the Chinese market's reliance on imports highlights the urgent need for a cost-effective, efficient, and domestically produced surgical scalpel. This study aimed to compare SanAgile^TMSA01 with the Johnson & Johnson GEN11, and HAR36 surgical devices.

Research design and methods: In total, 152 participants requiring urological or general laparoscopic surgery were randomly and equally divided between the two hospitals and randomized to the test and control groups. Clinical outcomes, adverse event rates, intraoperative bleeding, and surgery duration were compared between the two devices.

Results: The clinical application rate of both devices was 100%. There were no significant differences between the two groups in intraoperative bleeding, surgery duration, and incidence of adverse events. In the test group, five device-related adverse events occurred (6.58%), compared to two (2.63%) in the control group (no significant difference). The device-related adverse events did not result in any sequelae.

Conclusions: The clinical performance of the SanAgile^TMSA01 was comparable to that of the Johnson & Johnson GEN11 and HAR36. The SanAgile^TMSA01 device may serve as a viable alternative ultrasonic surgical tool, thereby providing clinicians with additional options.

Trial registration: Registration number of Shanghai Medical Equipment Preparation 20,190,114.