Safety and Performance Evaluation of the AutoLap System
NCT ID: NCT01828580
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2012-12-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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AutoLap
active laparoscope positioner (AutoLap)
Interventions
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active laparoscope positioner (AutoLap)
Eligibility Criteria
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Inclusion Criteria
2. Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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M.S.T. Medical Surgery Technology LTD.
INDUSTRY
Responsible Party
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Locations
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Assuta Medical Center
Tel Aviv, Israel, Israel
Niguarda Cà Granda Hospital
Milan, , Italy
Meander Medisch Centrum
Amersfoort, , Netherlands
Countries
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Other Identifiers
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AL-65-001
Identifier Type: -
Identifier Source: org_study_id