Safety and Performance Evaluation of the AutoLap System

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

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

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

Intervention / Treatment
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* Device: active laparoscope positioner (AutoLap)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AutoLap<br> | Device: active laparoscope positioner (AutoLap)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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 | participants will be followed for the duration of hospital stay, an expected average of 1-2 days | 
| Performance evaluation | The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position | during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| system set-up time | defined as the time required from connecting the AutoLap's ARM to the bed rail | during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | 
| Average total procedure time | defined as the time from first abdominal incision until the surgical procedure is completed | during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | 
| Number of times that the laparoscope was removed for cleaning |  | During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | 
| Usability evaluation | 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 | During surgery (at the end of the procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder