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NCT02070068 · ClinicalTrials.gov registry record · Early Phase 1
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, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 38
- Enrollment target
NCT02070068: Completed Early Phase 1 study, sponsored by University of California, Los Angeles.
NCT02070068 is a Early Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 38 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02070068, a Early Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 38 participants
- Enrollment target
Study 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. 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.
Interventions
- DEVICE PINPOINT System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-11 |
| Phase | Early Phase 1 |
What the finished NCT02070068 record still lists
NCT02070068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which PINPOINT System is the first listed.
NCT02070068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02070068 about?
NCT02070068 is a clinical study titled "A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System 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 the...
What is the current status of trial NCT02070068?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 38 participants. The study started on 2014-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02070068?
The interventions under investigation include: PINPOINT System (DEVICE).
Who is sponsoring clinical trial NCT02070068?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02070068's enrollment target sits among peer trials
38 699th of 2000 higher than 1,298 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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