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
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.
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Device: Gallbladder retraction
The gallbladder will be retracted using the Endograb retractor
Other Name: Endograb
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- 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 ]
- No adverse effects related directly to the use of the Endograb retractor. [ Time Frame: 1 year ]

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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

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