CompletedNot Applicable

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

United States46 participantsStarted 2015-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Image stability

Timeframe: during surgery, an expected average of 1 hour

Usability

Timeframe: post surgery, an expected average of 3 minutes

Trial details

NCT IDNCT02346552

SponsorM.S.T. Medical Surgery Technology LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More General Laparoscopic Surgery Candidate trials