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Evaluation of Laparoscopic Internal Retractor Device

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ClinicalTrials.gov Identifier: NCT00711581
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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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 Design
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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
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00711581


Locations
Israel
Yoav Mintz
Jerusalem, Israel, 91120
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
Study Director: Ram Elazary, MD Hadassah Medical Organization
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov 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
Cholecystectomy, Laparoscopic
Laparoscopy

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
 Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical