Liver CancerNCT01238653
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 accurate liver surface registration including 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2012
- 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 scheduled for a laparoscopic procedure where liver surface visualization and surface swabbing is feasible with standard port placement.
Who may be able to join
- Scheduled for laparoscopic procedure
- Had a preoperative CT image that includes the liver
Who cannot join
- Severe cirrhosis of the liver
- Kidney failure or dialysis
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC, Montefiore Hospital Liver Cancer Center
Pittsburgh, Pennsylvania, 15213
About this study
This study was designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies.
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 three dimensional (3D) image. The surgeon will accept or reject the registration accuracy.
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 computed tomography (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.
A total study population will include 20 subjects that complete the laparoscopic procedure scheduled.
- Conditions
- Liver Cancer
- Keywords
- liver, cancer, tumor, Pathfinder
- 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 accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.
The performance of accurate physical-to-image registrations obtained during laparoscopic procedures will be compared with open liver registrations obtained from previous validation studies during open liver procedures.
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 startNov 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Slow enrollment with limited population for study parameters.
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathfinder Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A. Geller, M.D., Principal investigator, UPMC, Montefiore Hospital Liver Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238653
- Sponsor's protocol ID
- PTI-LC-2009-02
- Status last verified
- Aug 2012
- First submitted
- 8 Nov 2010
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 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
- NCT01238653
- Acronym / sponsor ID
- PTI-LC-2009-02
- Conditions
- Liver Cancer
- Keywords
- liver, cancer, tumor, Pathfinder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment with limited population for study parameters.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pathfinder TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (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 accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies.
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 three dimensional (3D) image. The surgeon will accept or reject the registration accuracy.
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 computed tomography (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.
A total study population will include 20 subjects that complete the laparoscopic procedure 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 scheduled for a laparoscopic procedure where liver surface visualization and surface swabbing is feasible with standard port placement.
Key inclusion criteria (2 listed)
- Scheduled for laparoscopic procedure
- Had a preoperative CT image that includes the liver
Key exclusion criteria (3 listed)
- Severe cirrhosis of the liver
- 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 accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures
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. The performance of accurate physical-to-image registrations obtained during laparoscopic procedures will be compared with open liver registrations obtained from previous validation studies during open liver procedures.
Results and safety
The study was stopped early (reason given: Slow enrollment with limited population for study parameters.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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.
David A. Geller, M.D. principal investigator
UPMC, Montefiore Hospital Liver 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: stopped early, as of the sponsor's last update on 8 Aug 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 was stopped early (reason given: Slow enrollment with limited population for study parameters.). Results are not available in the source record.
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 accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures (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 8 Aug 2012.