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

August 27, 2018 updated by: M.S.T. Medical Surgery Technology LTD.
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 Overview

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Procedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope.
No Intervention: Group 2
Procedures will be performed with the assistance of human camera holder.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
System set-up time
Time Frame: during surgery, an expected average of 5 minutes
during surgery, an expected average of 5 minutes
Length of surgery
Time Frame: during surgery, an expected average of 1 hour
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
during surgery, an expected average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dmitry Nepomnayshy, MD, Lahey Hospital & Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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