Clinical trial NCT01828580: Safety and Performance Evaluation of the AutoLap System
Official title: Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Keywords: laparoscopic Cholecystectomy
Gallbladder removal
laparoscope holder
Lead sponsor: M.S.T. Medical Surgery Technology LTD.
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

Primary outcomes:
measure: Adverse events
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days
measure: Performance evaluation
timeFrame: during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Secondary outcomes:
measure: system set-up time
timeFrame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
measure: Average total procedure time
timeFrame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
measure: Number of times that the laparoscope was removed for cleaning
timeFrame: During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
measure: Usability evaluation
timeFrame: During surgery (at the end of the procedure)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Milano
country: Italy
facility: Niguarda Cà Granda Hospital
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
Study officials:
References: