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Completed

NCT Number: NCT01828580

Safety and Performance Evaluation of the AutoLap System

The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.

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Key information

Conditions

Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center, Tel Aviv, Israel

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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.
  • Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.

Exclusion criteria

  • Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
  • Pregnancy.
  • Obesity (BMI >35 Kg/m2).
  • Generalized peritonitis.
  • Septic shock from cholangitis.
  • Severe acute pancreatitis.
  • Uncorrected coagulopathy.
  • Previous abdominal operations which prevent safe abdominal access or progression of the procedure.
  • Advanced cirrhosis with failure of hepatic function.
  • Suspected gallbladder cancer.
  • Acute cholecystitis
  • Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
  • 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

active laparoscope positioner (AutoLap)

Device

Primary outcomes

  1. Adverse events

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days

    No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention

  2. Performance evaluation

    Time frame: during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).

    The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position

Secondary outcomes

  1. system set-up time

    Time frame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).

    defined as the time required from connecting the AutoLap's ARM to the bed rail

  2. Average total procedure time

    Time frame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).

    defined as the time from first abdominal incision until the surgical procedure is completed

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

    Time frame: During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).

  4. Usability evaluation

    Time frame: During surgery (at the end of the procedure)

    the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. The questionnaire assesses the surgeon's satisfaction with the use of the AutoLap in regard to easiness of use, convenient of movement control and its ability to be used in the OR without interfering with the surgical flow

Sponsors and collaborators

Lead sponsor

M.S.T. Medical Surgery Technology LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Dec 31, 2014

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.