Brain FunctionNCT00860483
Correlation of Laparoscopic Experience and Functional Brain Activation: A PET Scan Study
A study testing observational in people with Brain Function, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Brain Function
- What is being tested?
- observational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2009
- Phase
- Interventional
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Urology resident or fellow at Long-Island Jewish Hospital
- Urology attending surgeon with previous laparoscopic experience
- Medical Student Research Fellow with no previous laparoscopic experience
- Right hand dominant subjects
- No known neorologic defect reported by the subject -
Who cannot join
- Left-hand dominant subjects
- Self-reported neurologic defect reported by the subject -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: GAC 0201 Correlation of Laparoscopic Experience and Functional Brain Activation: A Pet Scan Study
The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.
- Conditions
- Brain Function
- Being tested
- observational
- Keywords
- Comparison of experienced and novice laparoscopic surgeons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
PET Scan
| Study group | Role | What they receive |
|---|---|---|
| observational | No intervention | This is an observational study. no intervention occurs in subjects. their performance in a laparoscopic trainer is observed and correlated with brain activity Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laparoscopic experience
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FunctionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Kavoussi, Northwell Health
- Investigators
- Louis R. Kavoussi, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860483
- Sponsor's protocol ID
- GCRC 0201
- Status last verified
- Dec 2012
- First submitted
- 10 Mar 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAC 0201 Correlation of Laparoscopic Experience and Functional Brain Activation: A Pet Scan Study
- ClinicalTrials.gov ID
- NCT00860483
- Acronym / sponsor ID
- GCRC 0201
- Conditions
- Brain Function
- Keywords
- Comparison of experienced and novice laparoscopic surgeons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Mar 2009 (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.
The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | No intervention | Other: observationalThis is an observational study. no intervention occurs in subjects. their performance in a laparoscopic trainer is observed and correlated with brain activity |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Urology resident or fellow at Long-Island Jewish Hospital
- Urology attending surgeon with previous laparoscopic experience
- Medical Student Research Fellow with no previous laparoscopic experience
- Right hand dominant subjects
- No known neorologic defect reported by the subject -
Key exclusion criteria (2 listed)
- Left-hand dominant subjects
- Self-reported neurologic defect reported by the subject -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalPET Scan | Other | observational |
Primary outcome
Laparoscopic experience
Time frame: 2010
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 5 Dec 2012.
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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.
Louis R. Kavoussi, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing observational in people with Brain Function, run by Northwell Health 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 5 inclusion and 2 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 5 Dec 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?
Laparoscopic experience (time frame: 2010). 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 5 Dec 2012; AzTrials last refreshed its copy on 1 Nov 2026.