Evaluation of Laparoscopic Internal Retractor Device

April 9, 2014 updated by: Hadassah Medical Organization

Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device

The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization
      • Jerusalem, Israel, 91120
        • Yoav Mintz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic cholelithiasis
  • Age 18-60
  • ASA 1-2
  • Able to sign an informed consent

Exclusion Criteria:

  • ASA 3 or more
  • Acute cholecystitis
  • Choledocholithiasis
  • Coagulation disorders
  • Patients on blood thinners
  • Use of Steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.
Device: Gallbladder retraction
The gallbladder will be retracted using the Endograb retractor
Other Names:
  • Endograb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
No adverse effects related directly to the use of the Endograb retractor.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yoav Mintz, MD, Hadassah Medical Organization
  • Study Director: Ram Elazary, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endograb-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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