Usability and Performance Evaluation of the AutoLap System

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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General Laparoscopic Surgery Candidate Bariatric Laparoscopic Surgery Candidate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

Procedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope.

Group Type EXPERIMENTAL

AutoLap

Intervention Type DEVICE

Group 2

Procedures will be performed with the assistance of human camera holder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AutoLap

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No