- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594834
Clinical Study on the Effects of Pulmonary Vessels on Cryoablation and Preventive Embolization Strategies
May 17, 2026 updated by: Haibo Shao
This Study Aims to Provide New Evidence for Optimizing the Lung Cryoablation Strategy by Targeting High-risk Individuals With Incomplete Ice Ball Morphology in Lung Cryoablation. This is Achieved Through the Use of Selective Pulmonary Artery Embolization.
This study targeted high-risk individuals with incomplete ablation and performed selective pulmonary artery embolization before lung cryoablation, which could enhance the therapeutic effect and reduce the risk of intraoperative bleeding.
Previous studies have shown that selective pulmonary artery embolization before ablation has no adverse reactions related to embolization.
In this study, gelatin sponge particles were used for selective pulmonary artery embolization.
Gelatin sponge is an absorbable embolic material that can be absorbed and degraded in the human body within about 7 days, which has high safety and a low probability of adverse reactions.
The surgical risks are detailed in the surgical protocol.
The study aims to optimize the lung cryoablation strategy for high-risk individuals with incomplete ablation, aiming to improve the prognosis of high-risk recurrent patients.
The two groups of patients underwent lung CT reexamination every three months after surgery to observe the tumor ablation situation.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals at high risk of incomplete ablation (for example, there are vessels with a diameter greater than 3mm within 1cm around the pulmonary nodule);
- Scheduled for lung cryoablation, meeting the surgical indications and without any specific contraindications;
- The long diameter of the lung tumor is less than 3cm;
- The single cryoablation needle will be used. -
Exclusion Criteria:
- Postoperative complications such as massive pneumothorax and bleeding occurred, which affected the observation of the ice ball's shape;
- Poor image quality or incomplete images. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
In this study, using DSA guidance, gelatin sponge particles were used to artificially embolize the thicker pulmonary arteries around the tumor, thereby reducing the heat sink effect and complications, and improving the efficacy of lung cryoablation.
|
|
No Intervention: control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ablation zone
Time Frame: Immediately assess the extent of the ablation after the ablation needle is withdrawn.
|
The CT images obtained during the operation are subjected to three-dimensional reconstruction, and the ROI is delineated.
The long diameter, short diameter and volume of the ablation area are measured.Compare the values of various aspects of the smiling areas between the experimental group and the control group.
|
Immediately assess the extent of the ablation after the ablation needle is withdrawn.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2030
Study Registration Dates
First Submitted
April 12, 2026
First Submitted That Met QC Criteria
May 17, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026GSlungcryo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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