Status:
COMPLETED
Safety and Performance Evaluation of the AutoLap System
Lead Sponsor:
M.S.T. Medical Surgery Technology LTD.
Conditions:
Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
Eligibility Criteria
Inclusion
- Signed and dated Informed Consent Form.
- Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01828580
Start Date
December 1 2012
End Date
June 1 2014
Last Update
December 31 2014
Active Locations (3)
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1
Assuta Medical Center
Tel Aviv, Israel, Israel, 69710
2
Niguarda Cà Granda Hospital
Milan, Italy, 20162
3
Meander Medisch Centrum
Amersfoort, Netherlands, 3800BM