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Evaluation of Laparoscopic Internal Retractor Device

This study has been completed.
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: July 8, 2008
Last updated: April 9, 2014
Last verified: June 2008
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 Intervention
Cholelithiasis Device: Gallbladder retraction

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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. [ Time Frame: 1 year ]

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

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Hadassah Medical Organization Identifier: NCT00711581     History of Changes
Other Study ID Numbers: Endograb-HMO-CTIL
Study First Received: July 8, 2008
Last Updated: April 9, 2014

Keywords provided by Hadassah Medical Organization:
Cholecystectomy, Laparoscopic

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on September 21, 2017