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SILS™ Port Laparoscopic Cholecystectomy Post Market Study

NCT00832767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2017-12-18

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

Conditions

  • Gallbladder Disease

Interventions

PROCEDURE

SILS™ port laparoscopic cholecystectomy

This interventional arm will have a single incision laparoscopic cholecystectomy procedure.

PROCEDURE

Four Port Laparoscopic Cholecystectomy

This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Jeffrey Marks, MD · Case Medical Center University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-09-30
Completion
2012-01-31

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832767 on ClinicalTrials.gov