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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 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants.

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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.

Interventions

  • DEVICE Radial Endobronchial Ultrasound Probe
  • DEVICE Flouroscopy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2018-04-06
Est. Completion 2018-10-03
Phase NA

What the Registry Record Tells You About NCT03506295

The ClinicalTrials.gov registry entry for NCT03506295 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Radial Endobronchial Ultrasound Probe is the first listed.

NCT03506295 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.