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

Description

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.

Study Start Date

January 2015

Estimated Completion Date

April 2016

Interventions

  • Device: AutoLap

Specialties

  • Surgery: Plastic/Reconstructive

MeSH Terms

  • AutoLap
  • General and Bariatric Laparoscopic Surgeries

Study ID

M.S.T. Medical Surgery Technology LTD. -- AL-65-004

Status

Unknown

Trial ID

NCT02346552

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

M.S.T. Medical Surgery Technology LTD.

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Lahey Hospital Medical Center - Burlington, Massachusetts 11.0 miles Dmitry Nepomnayshy MD 781-744-8572 Dmitry.Nepomnayshy@lahey.org

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