Evaluation of Safety and Efficacy of the EndoLift Liver Retractor

Withdrawn before enrolling · Not applicable

Conditions studied: Minimally Invasive Surgical Procedure, Laparoscopic Gastric Banding, Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Sleeve Gastrectomy, Laparoscopic Fundoplication Procedure, Laparoscopic Heller Myotomy, Laparoscopic Paraesophageal Hernia Repair, Laparoscopic Gastric Resection

In brief

The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device. The secondary goals of the study are to evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device and to identify 'best practices' for device utilization. This study evaluates the use of a specific type of liver retractor (EndoLift). Liver retractors are often necessary during MIS procedures, but this retractor is the only device which is deployed internally (NOT requiring additional skin punctures/incisions for placement of the liver retractor device). All patients undergoing minimally invasive surgery (MIS) at Duke Regional Hospital will be approached. The new device is expected to have a minimal risk safety profile. The investigators believe that these risks are no more than would be encountered by using any other commercially available retraction device available on the market today. Data will be collected and analyzed by the identified investigators. Continuous variables will be analyzed via T-test and Chi-square analysis will be applied to discontinuous variables. Statistical analysis software such as SPSS® will be utilized when necessary.

Key facts

Study ID

NCT02008409

Run by

Duke University

People needed

0

Starts

2011-11-01

Expected to finish

2014-02-01

Last updated by the study team

2015-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects eligible for this clinical study must fulfill all of the following:
• Subject is 18 years of age or older.
• Subject is scheduled for a MIS procedure:
• Laparoscopic Gastric Banding
• Laparoscopic Roux-en-Y Gastric Bypass
• Laparoscopic Sleeve Gastrectomy
• Laparoscopic Fundoplication Procedure (Nissen, Toupet, Dor, etc.)
• Laparoscopic Heller myotomy
• Laparoscopic paraesophageal hernia repair
• Laparoscopic gastric resection
• Subject is able to comprehend and give informed consent for participation in this study.

You may not qualify if…

• Subjects not eligible for this research study include those that have any of the following:
• Subject is unable to comprehend and give informed consent for participation in this study.
• Subject who are pregnant.

Where it is running

• Duke Regional Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.