Evaluation of Laparoscopic Internal Retractor Device
Not Applicable
Completed
- Conditions
- Cholelithiasis
- Interventions
- Device: Gallbladder retraction
- Registration Number
- NCT00711581
- Lead Sponsor
- Hadassah Medical Organization
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Gallbladder retraction Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method No adverse effects related directly to the use of the Endograb retractor. 1 year
Trial Locations
- Locations (2)
Yoav Mintz
🇮🇱Jerusalem, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel