A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique
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|ClinicalTrials.gov Identifier: NCT03649906|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Nodule, Solitary||Procedure: Optimized Localization Technique||Not Applicable|
A series of optimization and improvement measures were tried for the complications of the CT-guided micro-coil locating method. After discussion, the method of micro-coil pre-loaded in the puncture needle and sealed first, and then for subsequent locating has more advantageous. The method avoids the direct penetration of the puncture needle into the atmosphere during operation, and the operation is simpler. In vitro tests of isolated lung specimens and pre-tests of 9 clinical patients were carried out. The results showed that this method not only reduced the number of operators on site, but also had the tendency to shorten the operation time, reduce the incidence of pneumothorax, and improve the success rate. However, there is currently no rigorous scientific research to provide objective evidence for its safety and effectiveness.
Therefore, this study intends to use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study intends to use a single set of target values for non-randomized controlled trials, and enrolled 120 subjects who met the inclusion criteria. The small pulmonary nodules were located using an optimized pre-loaded microcoil puncture positioning method. Observe the clinical indicators such as pneumothorax incidence rate, positioning success rate, other complication rate, operation time, and number of operators, and evaluate the safety and effectiveness of the optimized CT-guided pulmonary nodule microcoil localization technique.|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Optimized Localization Group
Subjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative.
Procedure: Optimized Localization Technique
The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.
- The proportion of patients with pneumothorax. [ Time Frame: half an hour after positioning ]Pneumothorax definition: The chest radiograph is examined in the lateral position half an hour after positioning. If a clear pneumothorax line is seen on the chest radiograph, that is, the boundary line between the atrophic lung tissue and the pleural cavity, the pneumothorax is considered to occur.
- Positioning success rate [ Time Frame: thoracoscopic surgery ]The proportion of patients who are successfully positioned. The CT scan was used to determine that the micro-coil was positioned around the nodules in the lungs, and the push and recovery were smooth during the operation. The components did not fall off or tear during the process, which was successful.
- Operation time [ Time Frame: At the end of the positioning operation ]The time interval from the first scan to the last scan to confirm that the micro coil is left in place
- Number of operators [ Time Frame: At the end of the positioning operation ]Number of people involved in the positioning operation
- Proportion of patients with complications other than pneumothorax [ Time Frame: thoracoscopic surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649906
|Contact: li fengwei, MD||+86 firstname.lastname@example.org|
|Contact: chen yingtai, MDemail@example.com|
|Beijing aerospace general hospital||Recruiting|
|Beijing, Beijing, China, 100076|
|Contact: LI fengwei, DOC 15011315970 firstname.lastname@example.org|
|Principal Investigator:||li fengwei, MD||Beijing Aerospace General Hospital Thoracic surgery department|