Evaluation of Laparoscopic Internal Retractor Device - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00711581

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:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711581

Contacts

Contact: Arik Tzukert, DMD	00 972 2 6776095	arik@hadassah.org.il
Contact: Hadas Lemberg, PhD	00 972 2 6777572	lhadas@hadassah.org.il

Locations

Israel
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

No publications provided

Responsible Party:	Hadassah Medical Organization, Jerusalem, Israel ( Yoav Mintz MD )
Study ID Numbers:	Endograb-HMO-CTIL
Study First Received:	July 8, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00711581 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Cholecystectomy
Cholecystectomy, Laparoscopic
Laparoscopy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

ClinicalTrials.gov processed this record on September 11, 2009