NCT02008409

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

November 22, 2013

Last Update Submit

August 3, 2015

Conditions

Minimally Invasive Surgical ProcedureLaparoscopic Gastric BandingLaparoscopic Roux-en-Y Gastric BypassLaparoscopic Sleeve GastrectomyLaparoscopic Fundoplication ProcedureLaparoscopic Heller MyotomyLaparoscopic Paraesophageal Hernia RepairLaparoscopic Gastric Resection

Keywords

Minimally Invasive SurgeryEndoLift Liver Retractor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Effective use of the EndoLift Liver Retractor

    Up to 6 hours during the operative procedure

Other Outcomes (1)

  • Physician satisfaction

    Day 1 Post-op

Study Arms (1)

EndoLift Liver Retractor

EXPERIMENTAL

During surgery, the surgeon will use the new internal liver retractor device. The device will retract the subject's 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.

Device: EndoLift Liver Retractor

Interventions

EndoLift Liver RetractorDEVICE

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.

EndoLift Liver Retractor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Regional Hospital

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Dana Portenier, MD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 11, 2013

Study Start

November 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(1)