NCT00711581

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 10, 2014

Status Verified

June 1, 2008

Enrollment Period

2.8 years

First QC Date

July 8, 2008

Last Update Submit

April 9, 2014

Conditions

Cholelithiasis

Keywords

CholecystectomyCholecystectomy, LaparoscopicLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • No adverse effects related directly to the use of the Endograb retractor.

    1 year

Study Arms (1)

A

EXPERIMENTAL

Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.

Device: Gallbladder retraction

Interventions

Gallbladder retractionDEVICE

The gallbladder will be retracted using the Endograb retractor

Also known as: Endograb
A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatic cholelithiasis
  • Age 18-60
  • ASA 1-2
  • Able to sign an informed consent

You may not qualify if:

  • ASA 3 or more
  • Acute cholecystitis
  • Choledocholithiasis
  • Coagulation disorders
  • Patients on blood thinners
  • Use of Steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yoav Mintz

Jerusalem, 91120, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Yoav Mintz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Ram Elazary, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 9, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

April 10, 2014

Record last verified: 2008-06

Locations

IL(2)