Evaluation of Laparoscopic Internal Retractor Device

Cholelithiasis Clinical Trial

Official title:

Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711581
• Other study ID #: Endograb-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: April 9, 2014
• Start date: August 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• Gallbladder retraction
The gallbladder will be retracted using the Endograb retractor

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Yoav Mintz	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	No adverse effects related directly to the use of the Endograb retractor.		1 year	Yes