Liver CancerNCT01237990
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
An observational study of Liver Cancer, run by Pathfinder Therapeutics at 1 site in United States.
Trial summary
This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any subject with liver cancer scheduled for a laparoscopic staging and open liver resection procedure.
Who may be able to join
- Clinical Diagnosis of Liver Cancer
- Scheduled for liver surgery
Who cannot join
- Receiving a liver transplant
- Kidney failure or dialysis
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure during the laparoscopic procedure. Under the presence of both insufflation pressures, the surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system 3D image. The surgeon will accept or reject the registration accuracy. Upon completion of the scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled for the surgical case. An open liver registration will be obtained with manual swabbing of the liver using the study tracked probe and will be accepted or rejected by the surgeon using the process described in the laparoscopic procedure.
In the event that the disease is determined to be too great for surgical repair during the laparoscopic staging procedure, only minimally invasive liver surface data will be acquired and the patient will not be included in the overall study population.
Read the detailed description
The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.
Preoperative CT scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.
During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.
For the purposes of the study, subjects will be enrolled following the inclusion/exclusion criteria below:
Inclusion:
- Written informed consent must be obtained.
- Patients enrolled must be undergoing a staging laparoscopy for with the intention for conversion to laparotomy.
- Patient must be 18 years of age or older.
- Women of childbearing age without documented evidence of menopause or sterility must have a negative serum or urine pregnancy test at the time of screening.
Exclusion:
- Any condition which, in the judgement of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- Patients that have a condition rendering them unable to understand the nature, scope and possible consequences of this study and therefore unable to give proper consent.
- Patients with Cirrhosis of the liver classified as Child-Pugh B or C.
- Patients undergoing liver surgery for the purpose of receiving a liver transplant.
- Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.
A total study population will include 20 subjects that complete both the laparoscopic and open liver procedures scheduled.
- Conditions
- Liver Cancer
- Keywords
- liver, cancer, tumor
- Medical subject headings
- Liver Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data.
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.
Measured: 30 Days
Secondary outcomes (1)
Comparison of registration errors from the full and half sufflation pressures to determine an impact of insufflation pressure on registration accuracy.
Subjects are followed for the study up to 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathfinder Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Jarnagin, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237990
- Sponsor's protocol ID
- PTI-LC-2009-01
- Status last verified
- Jan 2012
- First submitted
- 8 Nov 2010
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
- ClinicalTrials.gov ID
- NCT01237990
- Acronym / sponsor ID
- PTI-LC-2009-01
- Conditions
- Liver Cancer
- Keywords
- liver, cancer, tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pathfinder TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure during the laparoscopic procedure. Under the presence of both insufflation pressures, the surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system 3D image. The surgeon will accept or reject the registration accuracy. Upon completion of the scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled for the surgical case. An open liver registration will be obtained with manual swabbing of the liver using the study tracked probe and will be accepted or rejected by the surgeon using the process described in the laparoscopic procedure.
In the event that the disease is determined to be too great for surgical repair during the laparoscopic staging procedure, only minimally invasive liver surface data will be acquired and the patient will not be included in the overall study population.
Detailed description
The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.
Preoperative CT scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.
During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.
For the purposes of the study, subjects will be enrolled following the inclusion/exclusion criteria below:
Inclusion:
- Written informed consent must be obtained.
- Patients enrolled must be undergoing a staging laparoscopy for with the intention for conversion to laparotomy.
- Patient must be 18 years of age or older.
- Women of childbearing age without documented evidence of menopause or sterility must have a negative serum or urine pregnancy test at the time of screening.
Exclusion:
- Any condition which, in the judgement of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- Patients that have a condition rendering them unable to understand the nature, scope and possible consequences of this study and therefore unable to give proper consent.
- Patients with Cirrhosis of the liver classified as Child-Pugh B or C.
- Patients undergoing liver surgery for the purpose of receiving a liver transplant.
- Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.
A total study population will include 20 subjects that complete both the laparoscopic and open liver procedures scheduled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any subject with liver cancer scheduled for a laparoscopic staging and open liver resection procedure.
Key inclusion criteria (2 listed)
- Clinical Diagnosis of Liver Cancer
- Scheduled for liver surgery
Key exclusion criteria (3 listed)
- Receiving a liver transplant
- Kidney failure or dialysis
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data.
Time frame: 30 Days
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.
1 secondary outcome
Comparison of registration errors from the full and half sufflation pressures to determine an impact of insufflation pressure on registration accuracy.
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
- Pathfinder Company LinkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Jarnagin, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Pathfinder Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.