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Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer

NCT06832956 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-18

No results posted yet for this study

Summary

The goal of this single-arm clinical trial is to evaluate the safety and efficacy of robotic bronchoscopy system (RBS)-assisted cryoablation in the treatment of primary lung cancer in adult patients (aged ≥18 years) with histologically confirmed non-resectable primary lung cancer, regardless of gender. The main questions it aims to answer are:

Does RBS-assisted cryoablation achieve a predefined target technical success rate for complete tumor ablation under imaging guidance? Is the incidence of severe procedure-related adverse events within an acceptable safety threshold ?

Participants will:

Provide written informed consent for RBS-assisted cryoablation.

Undergo pretreatment evaluations, including:

Multimodal imaging (CT/PET-CT) for tumor localization and staging. Pulmonary function tests and cardiopulmonary risk assessment. Receive RBS-guided cryoablation therapy under general anesthesia. Be monitored for intraoperative complications and postoperative adverse events for 72 hours.

Complete follow-up assessments at 1, 3, 6, and 12 months post-procedure, including:

Contrast-enhanced CT scans to evaluate local tumor control. Documentation of symptom progression and quality-of-life metrics.

Conditions

  • Lung Cancer Patients

Interventions

PROCEDURE

robotic bronchoscopy system

cryobiopsy with the help of RBS

Sponsors & Collaborators

  • Guangzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832956 on ClinicalTrials.gov