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Evaluation of Safety and Efficacy of the EndoLift Liver Retractor

NCT02008409 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-08-05

No results posted yet for this study

Summary

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.

Conditions

  • 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

Interventions

DEVICE

EndoLift Liver Retractor

During the surgery, the surgeon will use the new internal liver retractor device. The device will retract the liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is "clipped" onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends.

Sponsors & Collaborators

Principal Investigators

  • Dana Portenier, MD · Duke University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02008409 on ClinicalTrials.gov