SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Completed · Not applicable

Conditions studied: Gallbladder Disease

In brief

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 Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.

Key facts

Study ID

NCT00832767

Run by

Medtronic - MITG

People needed

202

Starts

2009-04-01

Expected to finish

2012-01-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale New Haven Medical Center — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• North Shore - Long Island Jewish Health System — Lake Success, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Case Medical Center — Cleveland, Ohio, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Catholic University of Sacred Heart — Rome, Italy
• Imperial College, England, St. Mary's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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