Evaluation of Laparoscopic Internal Retractor Device

Hadassah Medical Organization10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cholelithiasis

Interventions

Gallbladder retractionDEVICE

The gallbladder will be retracted using the Endograb retractor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Yoav Mintz

Jerusalem, Israel

Hadassah Medical Organization

Jerusalem, Israel

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

Secondary Outcomes

No adverse effects related directly to the use of the Endograb retractor.

Time frame: 1 year

Data from ClinicalTrials.gov

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