Safety and Performance Evaluation of the AutoLap System

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MST Medical Surgery Technologies
Sponsor:
Information provided by (Responsible Party):
MST Medical Surgery Technologies
ClinicalTrials.gov Identifier:
NCT01828580
First received: April 3, 2013
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Device: active laparoscope positioner (AutoLap)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Performance Evaluation of the AutoLap System - a Feasibility Study

Further study details as provided by MST Medical Surgery Technologies:

Primary Outcome Measures:
  • Adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). ] [ Designated as safety issue: No ]
    The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    defined as the time required from connecting the AutoLap's ARM to the bed rail

  • 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). ] [ Designated as safety issue: No ]
    defined as the time from first abdominal incision until the surgical procedure is completed

  • 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). ] [ Designated as safety issue: No ]
  • Usability evaluation [ Time Frame: During surgery (at the end of the procedure) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AutoLap Device: active laparoscope positioner (AutoLap)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828580

Contacts
Contact: Dafna Carmi-Yinon, M.Sc. +972 (0) 73-796-5570 dafna@mst-sys.com

Locations
Israel
Assuta Medical Center Recruiting
Tel Aviv, Israel, 69710
Contact: Amir Szold, MD    972-37645444    amikisz@gmail.com   
Principal Investigator: Amir Szold, MD         
Italy
Niguarda Cà Granda Hospital Recruiting
Milano, Italy, 20162
Contact: Antonello Forgione, MD    +390264447600    Antonello.Forgione@aimsacademy.org   
Principal Investigator: Antonello Forgione, MD         
Netherlands
Meander Medisch Centrum Recruiting
Amersfoort, Netherlands, 3800BM
Contact: Ivo A. M. J. Broeders, MD    +31338501167    IAMJ.Broeders@meandermc.nl   
Principal Investigator: Ivo A. M. J. Broeders, MD         
Sponsors and Collaborators
MST Medical Surgery Technologies
  More Information

No publications provided

Responsible Party: MST Medical Surgery Technologies
ClinicalTrials.gov Identifier: NCT01828580     History of Changes
Other Study ID Numbers: AL-65-001
Study First Received: April 3, 2013
Last Updated: March 30, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by MST Medical Surgery Technologies:
laparoscopic Cholecystectomy
Gallbladder removal
laparoscope holder

ClinicalTrials.gov processed this record on September 18, 2014