Feasibility and Usability of LaparoGuard

Laparoscopic Surgical Procedures Clinical Trial

Official title: A Pilot Study Evaluating the Feasibility and Usability of the LaparoGuard System During Laparoscopic Surgical Procedures

Status Enrolling by invitation

Clinical Trial Summary

LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the patient during a laparoscopic surgery. The surgeon then receives notification throughout the procedure whenever a tracked rigid instrument has exited that volume. This open label, prospective, feasibility, single site, multi-investigator trial will evaluate the feasibility and usability of the LaparoGuard system during laparoscopic surgical procedures.

Clinical Trial Description

PHASE 1) LaparoGuard will be used as an adjunctive tool for maintaining safety during procedures performed by expert surgeons. The pre-operative instructions for use will be evaluated along with ease of procedural setup, as reported by pre-operative nurses. The intraoperative instructions for use will be evaluated along with system usability, as reported by the expert surgeons. The perceived clinical utility will be judged by expert surgeons. Postoperatively, the system data will be reviewed. This phase will include 4-6 subjects.

PHASE 2) Novice surgeons will conduct procedures alongside expert surgeons. Expert surgeons will establish the safe zone. LaparoGuard will record all deviations, speed and smoothness of tip movements. The training utility of LaparoGuard will be assessed by both the expert and novice surgeons. This phase will include 4-6 subjects. ;

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

• NCT number: NCT03503929
• Study type: Interventional
• Source: Mariner Endosurgery
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 21, 2019
• Completion date: October 30, 2024