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NCT03506295 · ClinicalTrials.gov registry record · NA
CrYobiopsy With Radial UltraSound Guidance
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03506295: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT03506295 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03506295, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Transbronchial cryobiopsy carries a higher chance of establishing pathological diagnosis in diffuse parenchymal lung disease (DPLD) than traditional transbronchial forceps guided biopsy. It is a novel technique capable of obtaining large, high-quality samples of lung tissue in a minimally invasive manner. This procedure may decrease the need for surgical lung biopsy in 75% of cases. However, there is an increased risk of pneumothorax and airway bleeding compared to traditional transbronchial forceps guided biopsy. Several strategies are used by practitioners of this technique to mitigate the risks of significant bleeding and pneumothorax. These include prophylactic placement of an endobronchial blocker, the use of fluoroscopy guidance, instillation of cold saline to promote vasoconstriction, and establishment of a secure airway with endotracheal tube placement or rigid bronchoscopy . Vanderbilt University Medical Center is one of the most active centers in terms of cryobiopsies performed as part of the diagnostic workup of DPLD. Currently all transbronchial cryobiopsies here are performed under fluoroscopic guidance, with endotracheal tube intubation and endobronchial blocker placement. Despite these precautions, post biopsy bleeding complications occur and can substantially lengthen the duration of the procedure and occasionally expose patients to procedural complications. Radial ultrasound has been well utilized to define anatomy of peripheral lung and localization of peripheral pulmonary nodules. We postulate that using radial ultrasound to identify peribronchial lung parenchyma with low vascularity will mitigate the risk of hemorrhage during peripheral lung cryobiopsy in patients with DPLD and hence improve patient safety.
Primary Outcome
This is defined as time from when the bronchoscope and cryoprobe are removed en bloc after obtaining the cryobiopsy to the time when it is determined to be safe to proceed to next cryobiopsy("Ready for next biopsy").
Interventions
- DEVICE Radial Endobronchial Ultrasound Probe
- DEVICE Flouroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-04-06 |
| Est. Completion | 2018-10-03 |
| Phase | NA |
What the finished NCT03506295 record still lists
NCT03506295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Radial Endobronchial Ultrasound Probe is the first listed.
NCT03506295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03506295 about?
NCT03506295 is a clinical study titled "CrYobiopsy With Radial UltraSound Guidance". Transbronchial cryobiopsy carries a higher chance of establishing pathological diagnosis in diffuse parenchymal lung disease (DPLD) than traditional transbronchial forceps guided biopsy. It is a novel technique capable of obtaining large, high-quality samples of lung tissue in a minimally invasive m...
What is the current status of trial NCT03506295?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-04-06. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT03506295?
The interventions under investigation include: Radial Endobronchial Ultrasound Probe (DEVICE), Flouroscopy (DEVICE).
Who is sponsoring clinical trial NCT03506295?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03506295's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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