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NCT05567003 · ClinicalTrials.gov registry record · Phase 4
Percutaneous Endoluminal Benign Biliary Laser
A Phase 4 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT05567003: Clinical Trial Phase 4 study, sponsored by University of California, Los Angeles.
NCT05567003 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05567003, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is being done to evaluate the safety and efficacy of Percutaneous transhepatic cholangioscopic (PTCS) laser incision as an ancillary therapy to traditional approaches such as balloon dilation and large drain placement for Benign Biliary Strictures (BBS). Narrowing or blockage of the bile ducts (biliary stricture) is a difficult to treat medical condition that leads to life-threatening complications. Treatment usually involves multiple procedures or surgeries spanned over months or years, and in many cases, leads to the need for a life-long tube that drains bile fluid outside of the body and into a bag. PTCS laser incision is a promising new treatment for bile duct strictures. The procedure is performed by an Interventional Radiologist who uses a tiny camera (endoscope) and a laser through a small hole in the skin to open up the blocked or narrowed duct. This allows bile to flow freely where it is supposed to go (without a tube) so that it does not backup up and cause life-threatening problems. Based on early experience from patients who have had this procedure done, it appears to be safe and effective, and may lead to needing fewer procedures over time, with the possibility of living without a tube or drain. The main goal of this study is to confirm the safety and efficacy of PTCS laser incision in a series of patients with benign biliary strictures who would otherwise receive standard treatment with long-term biliary tube drainage.
Primary Outcome
Safety evaluated by cumulative rates of post-interventional complications after PTCS-guided laser incision. 1. Complications will be reported according to the Society of Interventional Radiology Adverse Event (AE) classification system. 2. Safety will be reported as 30-day composite of all post-procedure AEs. 3. Complications will be further qualified and quantified by AE severity category and individual AE types.
Interventions
- PROCEDURE Percutaneous transhepatic cholangioscopic (PTCS) laser incision
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2024-02-05 |
| Phase | Phase 4 |
Why NCT05567003 stopped before completion
NCT05567003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Percutaneous transhepatic cholangioscopic (PTCS) laser incision is the first listed.
NCT05567003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05567003 about?
NCT05567003 is a clinical study titled "Percutaneous Endoluminal Benign Biliary Laser". This study is being done to evaluate the safety and efficacy of Percutaneous transhepatic cholangioscopic (PTCS) laser incision as an ancillary therapy to traditional approaches such as balloon dilation and large drain placement for Benign Biliary Strictures (BBS). Narrowing or blockage of the bile...
What is the current status of trial NCT05567003?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2022-11-01. Estimated completion is 2024-02-05.
What interventions are being tested in trial NCT05567003?
The interventions under investigation include: Percutaneous transhepatic cholangioscopic (PTCS) laser incision (PROCEDURE).
Who is sponsoring clinical trial NCT05567003?
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 NCT05567003's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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