Viewing Study NCT03649906



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Last Modification Date: 2024-10-26 @ 12:52 PM
Study NCT ID: NCT03649906
Status: COMPLETED
Last Update Posted: 2021-06-16
First Post: 2018-08-26

Brief Title: A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique
Sponsor: Beijing Aerospace General Hospital
Organization: Beijing Aerospace General Hospital

Study Overview

Official Title: A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique
Status: COMPLETED
Status Verified Date: 2021-06
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: None
Brief Summary: In the early stage of the study the CT-guided micro-coil locating method for pulmonary small nodules was optimized This study will 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
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?: None
Is an FDA AA801 Violation?: None