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Evaluation of Laparoscopic Internal Retractor Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711581
First Posted: July 9, 2008
Last Update Posted: April 10, 2014
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.
Information provided by (Responsible Party):
Hadassah Medical Organization
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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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
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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00711581     History of Changes
Other Study ID Numbers: Endograb-HMO-CTIL
First Submitted: July 8, 2008
First Posted: July 9, 2008
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