Safety and Performance Evaluation of the AutoLap System

M.S.T. Medical Surgery Technology LTD.36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

active laparoscope positioner (AutoLap)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed and dated Informed Consent Form. 2. Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure. Exclusion Criteria: 1. Previous upper abdominal surgery and contraindications to Pneumoperitoneum. 2. Pregnancy. 3. Obesity (BMI \>35 Kg/m2). 4. Generalized peritonitis. 5. Septic shock from cholangitis. 6. Severe acute pancreatitis. 7. Uncorrected coagulopathy. 8. Previous abdominal operations which prevent safe abdominal access or progression of the procedure. 9. Advanced cirrhosis with failure of hepatic function. 10. Suspected gallbladder cancer. 11. Acute cholecystitis 12. 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. 13. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Locations (3)

Assuta Medical Center

Tel Aviv, Israel, Israel

Niguarda Cà Granda Hospital

Milan, Italy

Meander Medisch Centrum

Amersfoort, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 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

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

Secondary Outcomes

system set-up time

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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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