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

Not Applicable

Completed

• Conditions: Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

• Registration Number: NCT02326870
• Lead Sponsor: M.S.T. Medical Surgery Technology LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-21
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of successful "Follow Me" movements	during surgery
Length of procedure	during surgery
Number of times that the laparoscope was removed for cleaning	during surgery
System set-up time	during surgery
AutoLap evaluation questionnaire	post surgery

Secondary Outcome Measures

Name	Time	Method
System repositioning	during surgery

Trial Locations

Locations (3)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands