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OpenTrials
Completed

NCT Number: NCT02346552

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

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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Key information

Conditions

General Laparoscopic Surgery Candidate Bariatric Laparoscopic Surgery Candidate Hernia Hernia, Diaphragmatic Hernia, Hiatal 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

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

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 who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures

Exclusion criteria

  • Extensive adhesions that will preclude routine laparoscopic surgical approach.
  • Pregnancy
  • Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Treatment and study plan

AutoLap

Device

Primary outcomes

  1. Image stability

    Time frame: during surgery, an expected average of 1 hour

    measured by the vibrations of inertial sensors

  2. Usability

    Time frame: post surgery, an expected average of 3 minutes

    The ease of use of the AutoLap system will be evaluated by a set of questionnaires

Secondary outcomes

  1. System set-up time

    Time frame: during surgery, an expected average of 5 minutes

  2. Length of surgery

    Time frame: during surgery, an expected average of 1 hour

  3. The Number of times that the laparoscope was removed for cleaning

    Time frame: during surgery, an expected average of 1 hour

Sponsors and collaborators

Lead sponsor

M.S.T. Medical Surgery Technology LTD.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2015
Registry last updated
Aug 29, 2018

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.

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