Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder

August 27, 2018 updated by: M.S.T. Medical Surgery Technology LTD.
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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

  • Netherlands
      • Amersfoort, Netherlands, 3800BM
        • Meander Medisch Centrum

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. Aged ≥ 18 years
  2. Able to provide a written informed consent

Exclusion Criteria:

  1. Pregnancy
  2. Obesity (BMI >35 Kg/m2)
  3. Contra-indications for performing laparoscopy

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Patients in this group will undergo an elective standard laparoscopic procedure with a designated OR staff to maneuver the laparoscopic camera. The procedures will be performed according to the hospital and OR routine procedure.
EXPERIMENTAL: AutoLap Group
Patients in this group will undergo a laparoscopic procedure using the AutoLap system. In this group the surgeon will use the AutoLap system to hold and control the movements of the laparoscopic camera.
Device: AutoLap system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate in performing an operation with at least one OR person less
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of the operation
Time Frame: During surgery
During surgery
Number of times the laparoscope is removed for cleaning
Time Frame: During surgery
During surgery
Usability evaluation
Time Frame: Up to two days post surgery
Up to two days 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

September 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (ESTIMATE)

October 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AL-65-006-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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