Safety and Performance Evaluation of the AutoLap System

Not Applicable

Completed

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

• Registration Number: NCT01828580
• Lead Sponsor: M.S.T. Medical Surgery Technology LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-07
• Study First Posted: 2013-04-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance evaluation	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
Adverse events	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

Secondary Outcome Measures

Name	Time	Method
Average total procedure time	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
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	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
system set-up time	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

Trial Locations

Locations (3)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel

Niguarda Cà Granda Hospital; 🇮🇹 Milano, Italy

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands