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

Not Applicable

Completed

• Conditions: General Laparoscopic Surgery Candidate; Bariatric Laparoscopic Surgery Candidate

• Registration Number: NCT02346552
• Lead Sponsor: M.S.T. Medical Surgery Technology LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Status Verified: 2016-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Image stability	during surgery, an expected average of 1 hour	measured by the vibrations of inertial sensors
Usability	post surgery, an expected average of 3 minutes	The ease of use of the AutoLap system will be evaluated by a set of questionnaires

Secondary Outcome Measures

Name	Time	Method
System set-up time	during surgery, an expected average of 5 minutes
Length of surgery	during surgery, an expected average of 1 hour
The Number of times that the laparoscope was removed for cleaning	during surgery, an expected average of 1 hour

Trial Locations

Locations (1)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States