Back to resultsSafety and Performance Evaluation of the AutoLap System
Primary Purpose
Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
active laparoscope positioner (AutoLap)
Sponsored by
About this trial
This is an interventional supportive care trial for Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection focused on measuring laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder
Eligibility Criteria
Inclusion Criteria:
- Signed and dated Informed Consent Form.
- Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion Criteria:
- 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.
Sites / Locations
- Assuta Medical Center
- Niguarda Cà Granda Hospital
- Meander Medisch Centrum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AutoLap
Arm Description
Outcomes
Primary Outcome Measures
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
Performance evaluation
The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position
Secondary Outcome Measures
system set-up time
defined as the time required from connecting the AutoLap's ARM to the bed rail
Average total procedure time
defined as the time from first abdominal incision until the surgical procedure is completed
Number of times that the laparoscope was removed for cleaning
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
Full Information
NCT ID
NCT01828580
First Posted
April 3, 2013
Last Updated
December 30, 2014
Sponsor
M.S.T. Medical Surgery Technology LTD.
1. Study Identification
Unique Protocol Identification Number
NCT01828580
Brief Title
Safety and Performance Evaluation of the AutoLap System
Official Title
Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.S.T. Medical Surgery Technology LTD.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Keywords
laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AutoLap
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
active laparoscope positioner (AutoLap)
Primary Outcome Measure Information:
Title
Adverse events
Description
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
Title
Performance evaluation
Description
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 Outcome Measure Information:
Title
system set-up time
Description
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).
Title
Average total procedure time
Description
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).
Title
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).
Title
Usability evaluation
Description
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
Time Frame
During surgery (at the end of the procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated Informed Consent Form.
Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Assuta Medical Center
City
Tel Aviv
ZIP/Postal Code
69710
Country
Israel
Facility Name
Niguarda Cà Granda Hospital
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3800BM
Country
Netherlands
12. IPD Sharing Statement
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Safety and Performance Evaluation of the AutoLap System
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