Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study

M.S.T. Medical Surgery Technology LTD.33 enrolled

Overview

The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Interventions

AutoLapDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed and dated Informed Consent Form (ICF). 2. Patients over 18 years Exclusion Criteria: 1. Pregnancy 2. Extensive adhesions that will preclude routine laparoscopic surgical approach. 3. American Society of Anesthesiologists' (ASA) classification\>2

Locations (4)

Assuta Medical Center

Haifa, Israel

Assuta Medical Center

Tel Aviv, Israel

Meander Medisch Centrum

Amersfoort, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Number of successful "Follow Me" movements

Time frame: during surgery

System set-up time

Time frame: during surgery

Length of procedure

Time frame: during surgery

Number of times that the laparoscope was removed for cleaning

Time frame: during surgery

AutoLap evaluation questionnaire

Time frame: post surgery

Secondary Outcomes

System repositioning

Time frame: during surgery

Data from ClinicalTrials.gov

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