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

M.S.T. Medical Surgery Technology LTD.108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

108

Conditions

General Laparoscopic Surgeries

Interventions

AutoLap systemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Meander Medisch Centrum

Amersfoort, Netherlands

Outcomes

Primary Outcomes

Success rate in performing an operation with at least one OR person less

Time frame: During surgery

Secondary Outcomes

Duration of the operation

Time frame: During surgery

Number of times the laparoscope is removed for cleaning

Time frame: During surgery

Usability evaluation

Time frame: Up to two days post surgery

Data from ClinicalTrials.gov

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