Usability and Performance Evaluation of the AutoLap System - a Feasibility Study

M.S.T. Medical Surgery Technology LTD.46 enrolled

Overview

The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

General Laparoscopic Surgery Candidate Bariatric Laparoscopic Surgery Candidate

Interventions

AutoLapDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed and dated Informed Consent Form (ICF). 2. Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures Exclusion Criteria: 1. Extensive adhesions that will preclude routine laparoscopic surgical approach. 2. Pregnancy 3. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Locations (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

Image stability

measured by the vibrations of inertial sensors

Time frame: during surgery, an expected average of 1 hour

Usability

The ease of use of the AutoLap system will be evaluated by a set of questionnaires

Time frame: post surgery, an expected average of 3 minutes

Secondary Outcomes

System set-up time

Time frame: during surgery, an expected average of 5 minutes

Length of surgery

Time frame: during surgery, an expected average of 1 hour

The Number of times that the laparoscope was removed for cleaning

Time frame: during surgery, an expected average of 1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.