Evaluation of Laparoscopic Internal Retractor Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711581
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Device: Gallbladder retraction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
Study Start Date : August 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

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 Name: Endograb

Primary Outcome Measures :
  1. 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 Measures :
  1. No adverse effects related directly to the use of the Endograb retractor. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711581

Yoav Mintz
Jerusalem, Israel, 91120
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
Study Director: Ram Elazary, MD Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT00711581     History of Changes
Other Study ID Numbers: Endograb-HMO-CTIL
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: June 2008

Keywords provided by Hadassah Medical Organization:
Cholecystectomy, Laparoscopic

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical