Evaluation of Laparoscopic Internal Retractor Device

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00711581

First received: July 8, 2008

Last updated: April 9, 2014

Last verified: June 2008

History of Changes

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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

No adverse effects related directly to the use of the Endograb retractor. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]


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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
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

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 ClinicalTrials.gov identifier: 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
Study First Received:	July 8, 2008
Last Updated:	April 9, 2014
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 26, 2016

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