Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 12:38 PM
Study NCT ID:
NCT00690703
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation
Sponsor:
Angiodynamics, Inc.
Organization:
Study Overview
Official Title:
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2008-06
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:
RAPTURE
Brief Summary:
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
Detailed Description:
Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: