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Safety and Performance Evaluation of the AutoLap System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828580
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
M.S.T. Medical Surgery Technology LTD.

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

Condition or disease Intervention/treatment Phase
Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection Device: active laparoscope positioner (AutoLap) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: AutoLap Device: active laparoscope positioner (AutoLap)


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: 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

  2. Performance evaluation [ Time Frame: 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


Secondary Outcome Measures :
  1. system set-up time [ Time Frame: 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

  2. Average total procedure time [ Time Frame: 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

  3. 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). ]
  4. Usability evaluation [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828580


Locations
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Israel
Assuta Medical Center
Tel Aviv, Israel, 69710
Italy
Niguarda Cà Granda Hospital
Milano, Italy, 20162
Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands, 3800BM
Sponsors and Collaborators
M.S.T. Medical Surgery Technology LTD.
More Information
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Responsible Party: M.S.T. Medical Surgery Technology LTD.
ClinicalTrials.gov Identifier: NCT01828580    
Other Study ID Numbers: AL-65-001
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by M.S.T. Medical Surgery Technology LTD.:
laparoscopic Cholecystectomy
Gallbladder removal
laparoscope holder
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical