Skip to main content
OpenTrials
Completed

NCT Number: NCT02326870

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures Hernia Hernia, Diaphragmatic Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated Informed Consent Form (ICF).
  • Patients over 18 years

Exclusion criteria

  • Pregnancy
  • Extensive adhesions that will preclude routine laparoscopic surgical approach.
  • American Society of Anesthesiologists' (ASA) classification>2

Treatment and study plan

AutoLap

Device

Primary outcomes

  1. Number of successful "Follow Me" movements

    Time frame: during surgery

  2. System set-up time

    Time frame: during surgery

  3. Length of procedure

    Time frame: during surgery

  4. Number of times that the laparoscope was removed for cleaning

    Time frame: during surgery

  5. AutoLap evaluation questionnaire

    Time frame: post surgery

Secondary outcomes

  1. System repositioning

    Time frame: during surgery

Other outcomes

  1. Surgeon's learning curve for the use of the AutoLap system

    Time frame: post surgery

Sponsors and collaborators

Lead sponsor

M.S.T. Medical Surgery Technology LTD.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2014
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.