Usability and Performance Evaluation of the AutoLap System - a Feasibility Study

M.S.T. Medical Surgery Technology

Status: Completed

Conditions: Bariatric Laparoscopic Surgery Candidate; General Laparoscopic Surgery Candidate

Treatments: Device: AutoLap

Study type: Interventional

Funder types: Industry

Identifiers

NCT02346552

AL-65-004

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Device: AutoLap

Group 2

No Intervention group

Description:

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