Biliary AnatomyEarly Phase 1NCT02070068
A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations
A Early Phase 1 study testing PINPOINT System in people with Biliary Anatomy, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biliary Anatomy
- What is being tested?
- PINPOINT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2014
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the study, subjects must fulfill all of the following criteria:
- Subjects who are healthy men or women 18 years of age or older.
- Subjects who are scheduled for laparoscopic biliary or hepatic operations.
- Subjects who sign an approved informed consent form for the study.
- Subjects who are willing to comply with the protocol.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
- Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
- Subjects who are pregnant or lactating females.
- Subjects, who are actively participating in another investigational clinical study and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: A Pilot Study to Optimize Imaging When Utilizing the PINPOINT Endoscopic Fluorescence Imaging System for Identification of Biliary Anatomy During Laparoscopic Biliary and Hepatic Operations
Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Injury to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is an important source of patient morbidity. Serious injuries often require at least one surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the visualization of the bile ducts may prevent such an injury, by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation. This technique also allows the superimposition of the cholangiogram onto the normal image.
This study is being conducted to optimize an imaging technique called PINPOINT. Images will be obtained during clinically necessary operations. The images will be evaluated to determine the best method for locating and outlining the anatomy. The information learned will guide the future use of PINPOINT in laparoscopic procedures.
- Conditions
- Biliary Anatomy
- Being tested
- PINPOINT System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINPOINT SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ICG administered 10 minutes prior to time of visualization Receives: Device: PINPOINT System |
| Group 2 | Experimental | ICG administered 45 min prior to time of visualization Receives: Device: PINPOINT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)
Measured: 10 minutes after injection
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)
Measured: 45 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AnatomyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Responsible party
- Principal investigator, Ali Zarrinpar, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070068
- Sponsor's protocol ID
- PP LBH 01
- Status last verified
- Dec 2014
- First submitted
- 19 Feb 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Optimize Imaging When Utilizing the PINPOINT Endoscopic Fluorescence Imaging System for Identification of Biliary Anatomy During Laparoscopic Biliary and Hepatic Operations
- ClinicalTrials.gov ID
- NCT02070068
- Acronym / sponsor ID
- PP LBH 01
- Conditions
- Biliary Anatomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Novadaq Technologies ULC, now a part of Stryker
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Feb 2014 (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.
Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Injury to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is an important source of patient morbidity. Serious injuries often require at least one surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the visualization of the bile ducts may prevent such an injury, by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation. This technique also allows the superimposition of the cholangiogram onto the normal image.
This study is being conducted to optimize an imaging technique called PINPOINT. Images will be obtained during clinically necessary operations. The images will be evaluated to determine the best method for locating and outlining the anatomy. The information learned will guide the future use of PINPOINT in laparoscopic procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: PINPOINT SystemICG administered 10 minutes prior to time of visualization |
| Group 2 | Experimental | Device: PINPOINT SystemICG administered 45 min prior to time of visualization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are healthy men or women 18 years of age or older.
- Subjects who are scheduled for laparoscopic biliary or hepatic operations.
- Subjects who sign an approved informed consent form for the study.
- Subjects who are willing to comply with the protocol.
Key exclusion criteria (5 listed)
- Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
- Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
- Subjects who are pregnant or lactating females.
- Subjects, who are actively participating in another investigational clinical study and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this study.
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 |
|---|---|---|
| PINPOINT System | Device | Group 1, Group 2 |
Primary outcome
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)
Time frame: 10 minutes after injection
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)
Time frame: 45 minutes after injection
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 2 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PINPOINT System in people with Biliary Anatomy, run by University of California, Los Angeles 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 5 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 2 Dec 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale) (time frame: 10 minutes after injection). The study lists 2 primary outcomes in all. 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 2 Dec 2014.