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

NCT ID: NCT02934542

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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General Laparoscopic Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

AutoLap system

Intervention Type DEVICE

Interventions

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AutoLap system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.S.T. Medical Surgery Technology LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivo A. M. J. Broeders, MD

Role: PRINCIPAL_INVESTIGATOR

Meander Medisch Centrum

Locations

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Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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AL-65-006-P

Identifier Type: -

Identifier Source: org_study_id

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