Safety and Performance Evaluation of the AutoLap System

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

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

Study Overview

• Status: Completed
• Conditions: Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
• Intervention / Treatment: Device: active laparoscope positioner (AutoLap)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69710
    • Assuta Medical Center
• Italy
  • Milano, Italy, 20162
    • Niguarda Cà Granda Hospital
• Netherlands
  • Amersfoort, Netherlands, 3800BM
    • Meander Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AutoLap	Device: active laparoscope positioner (AutoLap)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: M.S.T. Medical Surgery Technology LTD.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 7, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Gallbladder removal; laparoscopic Cholecystectomy; laparoscope holder
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: AL-65-001