- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711581
Evaluation of Laparoscopic Internal Retractor Device
April 9, 2014 updated by: Hadassah Medical Organization
Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel
- Hadassah Medical Organization
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Jerusalem, Israel, 91120
- Yoav Mintz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Subjects will undergo a laparoscopic cholecystectomy.
The gallbladder will be retracted using the Endograb retractor.
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The gallbladder will be retracted using the Endograb retractor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
No adverse effects related directly to the use of the Endograb retractor.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoav Mintz, MD, Hadassah Medical Organization
- Study Director: Ram Elazary, MD, Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
July 8, 2008
First Submitted That Met QC Criteria
July 8, 2008
First Posted (Estimate)
July 9, 2008
Study Record Updates
Last Update Posted (Estimate)
April 10, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endograb-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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