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Evaluation of Laparoscopic Internal Retractor Device

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gallbladder retraction
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yoav Mintz
  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2008
Last Updated
April 9, 2014
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00711581
Brief Title
Evaluation of Laparoscopic Internal Retractor Device
Official Title
Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.
Intervention Type
Device
Intervention Name(s)
Gallbladder retraction
Other Intervention Name(s)
Endograb
Intervention Description
The gallbladder will be retracted using the Endograb retractor
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
No adverse effects related directly to the use of the Endograb retractor.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Mintz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ram Elazary, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Yoav Mintz
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Evaluation of Laparoscopic Internal Retractor Device

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