Evaluation of Safety and Efficacy of the EndoLift Liver Retractor

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title: Evaluation of Safety and Efficacy of the EndoLift Liver Retractor: a Pilot Study of a New Internal Laparoscopic Liver Retraction Device

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Since the introduction of minimally invasive surgery (MIS) techniques in the 1980's laparoscopic surgery has become the preferred approach for a number of intra-abdominal procedures such as cholecystectomy, gastric bypass, etc.[1] One of the key components of laparoscopic surgery, of any surgery for that matter, is the ability to achieve and maintain adequate visualization of the surgical target throughout the procedure. During certain MIS procedures the patient's internal organs, such as the liver, can block or obscure the surgical view. A number of surgical instruments (retractors) have been developed to help retract abdominal organs "out of the way" during MIS procedures, but all of these devices require an additional abdominal wall puncture/incision to adequately position the device.

Virtual Ports, Ltd. has developed a new laparoscopic liver retractor device, the EndoLift Liver Retractor. This new device does not require additional skin incisions and is placed internally (inside the abdomen) during laparoscopic surgery. The device has 2 ends that "grab" tissue. The body of the device is a smooth, cylindrical steel bar that has minimal risk of traumatizing tissues/organs. The ends of the device are positioned on to peritoneal surfaces (e.g., anterior abdominal wall and/or the right crus of the diaphragm) and the body of the device (smooth cylindrical bar) "pushes" the liver away from the surgical field. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

• NCT number: NCT02008409
• Study type: Interventional
• Source: Duke University
• Status: Withdrawn
• Phase: N/A
• Start date: November 2011
• Completion date: February 2014