Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000704796
Ethics application status
Approved
Date submitted
21/06/2013
Date registered
27/06/2013
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label Study of the Performance and Safety of the LiVac Retractor System in laparoscopic surgery
Scientific title
An Open-Label Study of the Performance and Safety of the LiVac Retractor System in laparoscopic surgery
Secondary ID [1] 282664 0
Protocol LIV_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic surgery 289363 0
Condition category
Condition code
Surgery 289701 289701 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 287328 0
Other interventions
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289796 0
Success or failure of the LiVac Retractor when used for liver retraction during upper abdominal laparoscopic surgery as assessed by milestones including successful insertion of device, retraction of liver, and removal of device
Timepoint [1] 289796 0
During surgical procedure
Secondary outcome [1] 303255 0
Success of failure of the LiVac bevel (if used) during upper abdominal laparoscopic surgery as assessed by whether procedure can proceed and device works.
Timepoint [1] 303255 0
During surgical procedure
Secondary outcome [2] 303256 0
Safety of the LiVvac Retractor and bevel (if used) during upper abdominal laparoscopic surgery as assessed by adverse events, laboratory assessments, physical examinations, vital signs, and post operative pain using an 11 point scale (0 -10)
Timepoint [2] 303256 0
During and 1 day post surgery, at hospital discharge, and 1 and 4 weeks post hospital discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
9/10/2013
Date of last participant enrolment
Anticipated
Actual
3/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287447 0
Government body
Name [1] 287447 0
Commercialisation Australia
Country [1] 287447 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
LiVac Pty Ltd
Address
8 Melaleuca Crt
Warrnambool
Victoria 3280
Country
Australia
Secondary sponsor category [1] 286189 0
None
Name [1] 286189 0
N/A
Address [1] 286189 0
N/A
Country [1] 286189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289422 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 289422 0
Level 3, St John of God House
177-179 Cambridge Street
Wembley WA 6014
Ethics committee country [1] 289422 0
Australia
Date submitted for ethics approval [1] 289422 0
28/06/2013
Approval date [1] 289422 0
11/09/2013
Ethics approval number [1] 289422 0
EC00286
Ethics committee name [2] 290194 0
South West Health Care Multidiscinplinary Ethics Committeee
Ethics committee address [2] 290194 0
Warrnambool Base Hospital
Ryot Street
Warrnambool VIC 3280
Ethics committee country [2] 290194 0
Australia
Date submitted for ethics approval [2] 290194 0
16/07/2013
Approval date [2] 290194 0
19/08/2013
Ethics approval number [2] 290194 0
EC00257

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40730 0
Dr Philip Gan
Address 40730 0
St John of God Hospital
136 Botanic Rd
Warrnambool
Victoria 3280
Country 40730 0
Australia
Phone 40730 0
+61 3 55622177
Fax 40730 0
+61 3 5562 9527
Email 40730 0
[email protected]
Contact person for public queries
Name 40731 0
Dr Philip Gan
Address 40731 0
St John of God Hospital
136 Botanic Rd
Warrnambool
Victoria 3280
Country 40731 0
Australia
Phone 40731 0
+61 3 55622177
Fax 40731 0
+61 3 5562 9527
Email 40731 0
[email protected]
Contact person for scientific queries
Name 40732 0
Dr Philip Gan
Address 40732 0
St John of God Hospital
136 Botanic Rd
Warrnambool
Victoria 3280
Country 40732 0
Australia
Phone 40732 0
+61 3 55622177
Fax 40732 0
+61 3 5562 9527
Email 40732 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.