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

Hadassah Medical Organization2 sites in 1 country10 target enrollmentAugust 2008

ConditionsCholelithiasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cholelithiasis
Sponsor: Hadassah Medical Organization
Enrollment: 10
Locations: 2
Primary Endpoint: 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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hadassah Medical Organization

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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