Active Not RecruitingNot applicableNCT06593106

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

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.

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

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations1
SponsorVanderbilt-Ingram Cancer Center
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

Inclusion 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 Exclusion 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 ↗