None listed
Conditions
Brief summary
Current methods of retracting the liver during surgery (to allow sight of and access to target surgical organs) can be traumatic or painful, and can require additional surgical assistants. The LiVac Retractor System has been developed to retract and hold the liver by suction, therefore reducing trauma and the need for extra assistance. This proof of concept study will assss how well the devices work during surgery and whether there are any safety issues.
Interventions
The LiVac Retractor and bevel device will be used during upper abdominal laparoscopic surgery on 10 patients to retract the liver and allow access to the target organs for surgery.
The retractor is placed between the liver and diaphragm and uses suction to retract the liver. The bevel allows passage of the suction tube through surgical ports
Sponsors
LiVac Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Male or female patients 18-65 years of age inclusive - Scheduled to undergo cholecystectomy for uncomplicated cholelithiasis or biliary pain, fundoplication or primary gastric banding laparoscopic surgery
Exclusion criteria
- Patients undergoing emergency procedures, revision surgery, or who have previously undergone major upper abdominal surgery - Pregnancy - Significant co-morbid disease or clinically significant medical conditions that in the investigator’s opinion, may increase the risk of surgery - Patients with common bile duct stones, active infection, BMI > 45 kg/m2, or history of chronic alcohol or drug abuse - Known Hepatitis B or C, or chronic liver disease with Childs-Pugh A, B or C, and/or cirrhosis - Patients with abnormal coagulation or who take anti-coagulation medication, or haematocrit less than 25 percent.
Outcome results
None listed