Status:
COMPLETED
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Lead Sponsor:
Medtronic - MITG
Conditions:
Gallbladder Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecys...
Eligibility Criteria
Inclusion
- Between 18 and 85 years old.
- Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF \< 30%.
- Body Mass Index (BMI) \< 45 kg/m2.
Exclusion
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- Any patient with acute calculus or acalculous cholecystitis.
- Any patient who has had an upper midline or right sub costal incision.
- Any patient with pre-operative indication for a cholangiogram.
- Any patient with ASA \> 3 with normal liver function.
- Any patient who is undergoing Peritoneal Dialysis (PD).
- Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00832767
Start Date
April 1 2009
End Date
January 1 2012
Last Update
December 18 2017
Active Locations (10)
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1
Yale New Haven Medical Center
New Haven, Connecticut, United States, 06510
2
Tampa General Hospital
Tampa, Florida, United States, 33601
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111