Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 6:35 PM
Study NCT ID:
NCT06832956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer
Sponsor:
Guangzhou Medical University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: