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A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649906
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Aerospace General Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule, Solitary Procedure: Optimized Localization Technique Not Applicable

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.

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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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Number of operators [ Time Frame: At the end of the positioning operation ]
    Number of people involved in the positioning operation

  4. Proportion of patients with complications other than pneumothorax [ Time Frame: thoracoscopic surgery ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
  2. The nodule is clinically suspected to be malignant;
  3. Those who have no distant metastases;
  4. Intrapulmonary lesions must meet the following imaging criteria: ① pure ground glass opacity or non-pure ground glass opacity of solid components ≦ 25%; ②solid nodules with diameter ≦ 1 cm or solid components≦ 1 cm non- purely ground glass, and the distance between the solid component of the nodule and the visceral pleural ≧0.5cm; ③ no pleural traction or involving the pleura.

Exclusion Criteria:

  1. The lesion site is not suitable for percutaneous lung puncture;
  2. those who have pneumothorax and pleural effusion;
  3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
  4. Those who refuse surgery;
  5. Those who did not sign the informed consent form.

Information from the National Library of Medicine

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


Contacts
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Contact: li fengwei, MD +86 15011315970 254103852@qq.com
Contact: chen yingtai, MD 13801076273 chenyingtai@xiongwai711.com

Locations
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China, Beijing
Beijing aerospace general hospital Recruiting
Beijing, Beijing, China, 100076
Contact: LI fengwei, DOC    15011315970    254103852@qq.com   
Sponsors and Collaborators
Beijing Aerospace General Hospital
Investigators
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Principal Investigator: li fengwei, MD Beijing Aerospace General Hospital Thoracic surgery department

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Responsible Party: Beijing Aerospace General Hospital
ClinicalTrials.gov Identifier: NCT03649906    
Other Study ID Numbers: Z181100001718055
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Our hospital medical ethics committee does not allow us to share patients personal data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Aerospace General Hospital:
Micro-coil
CT-guided locate
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases