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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02008409
• Other study ID #: Pro00028255
• Status: Withdrawn
• Phase: N/A
• First received: November 22, 2013
• Last updated: August 3, 2015
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: August 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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:

1. Laparoscopic Gastric Banding

2. Laparoscopic Roux-en-Y Gastric Bypass

3. Laparoscopic Sleeve Gastrectomy

4. Laparoscopic Fundoplication Procedure (Nissen, Toupet, Dor, etc.)

5. Laparoscopic Heller myotomy

6. Laparoscopic paraesophageal hernia repair

7. Laparoscopic gastric resection

• Subject is able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

• 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.

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

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Regional Hospital	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Virtual Ports

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician satisfaction	Physician satisfaction and surgeon recommendations for 'best practices' during utilization of the EndoLift Liver Retractor will be assessed by questionnaire.; Study outcomes will be measured within the hospitalization period.	Day 1 Post-op	No
Primary	Safety	The primary study endpoint will be to establish the safety of using the EndoLift Liver Retractor as an internal laparoscopic liver retraction device.; Safety will be established by lack of serious events. Events are defined as adverse if they require change in the operative course, a device specific complication and/or association with prolongation of hospital stay.	Day 1 post-op	Yes
Secondary	Effective use of the EndoLift Liver Retractor	The effective use of the EndoLift Liver Retractor as a liver retraction device during surgery will be considered a "success". If there is a need to use any additional equipment to retract the liver during the surgery, the subject will be scored a "failure".; Study success will be declared if at least 80% of subjects are scored a "success".	Up to 6 hours during the operative procedure	No