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OpenTrials
Completed

NCT Number: NCT00711581

Evaluation of Laparoscopic Internal Retractor Device

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gallbladder retraction

Device

The gallbladder will be retracted using the Endograb retractor

Other names: Endograb

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.

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2008
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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