Evaluation of Laparoscopic Internal Retractor Device

Hadassah Medical Center

Status: Completed

Conditions: Cholelithiasis

Treatments: Device: Gallbladder retraction

Study type: Interventional

Funder types: Other

Identifiers

NCT00711581

Endograb-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

A

Experimental group

Description:

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

Treatment:

Device: Gallbladder retraction