Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study

September 15, 2016 updated by: M.S.T. Medical Surgery Technology LTD.

Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study

The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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

  • Israel
      • Haifa, Israel
        • Assuta Medical Center
      • Tel Aviv, Israel
        • Assuta Medical Center
  • Netherlands
      • Amersfoort, Netherlands, 3800BM
        • Meander Medisch Centrum
      • Utrecht, Netherlands
        • University Medical Center Utrecht

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

Exclusion Criteria:

  1. Pregnancy
  2. Extensive adhesions that will preclude routine laparoscopic surgical approach.
  3. American Society of Anesthesiologists' (ASA) classification>2

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The AutoLap system
Use of the AutoLap system for controlling the laparoscope during the procedure
Device: AutoLap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of successful "Follow Me" movements
Time Frame: during surgery
during surgery
System set-up time
Time Frame: during surgery
during surgery
Length of procedure
Time Frame: during surgery
during surgery
Number of times that the laparoscope was removed for cleaning
Time Frame: during surgery
during surgery
AutoLap evaluation questionnaire
Time Frame: post surgery
post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
System repositioning
Time Frame: during surgery
during surgery

Other Outcome Measures

Outcome Measure
Time Frame
Surgeon's learning curve for the use of the AutoLap system
Time Frame: post surgery
post surgery

Collaborators and Investigators

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

Sponsor

M.S.T. Medical Surgery Technology LTD.

Investigators

  • Principal Investigator: Ivo A. M. J. Broeders, MD, Meander Medisch Centrum

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

December 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (ESTIMATE)

December 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AL-65-003

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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