Active Not RecruitingNot applicableNCT06593106
Official study title

Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

Study summary

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCryosurgery and Robotic Bronchoscopy

Plus 6 other study approaches.

Who it may be forEarly-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 18, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Vanderbilt-Ingram Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Vanderbilt-Ingram Cancer Center
Interventions being studied
Procedure: Cryosurgery; Procedure: Robotic Bronchoscopy; Procedure: Bronchoscopy with Biopsy; Procedure: Resection; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Electronic Health Record Review
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection
  • Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs
  • Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board
  • Age \> 18 years old
Reasons someone may not be able to joinExclusion criteria
  • Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are \< 10 mm from the pleura
  • Patients with an expected survival less than 6 months
  • Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
  • Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5
  • Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg)
  • Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
  • Patients with medical comorbidities deemed high-risk for surgical resection
  • Pregnant women
  • Inability to provide informed consent

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Vanderbilt University/Ingram Cancer CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2026. Always confirm current availability with the study team.

View original record ↗