Pulmonary Nodule, SolitaryNCT03649906

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

A study testing Optimized Localization Technique in people with Pulmonary Nodule, Solitary, run by Beijing Aerospace General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Pulmonary Nodule, Solitary
What is being tested?: Optimized Localization Technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteChina
Study dates: 1 Sep 2018to 15 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
The nodule is clinically suspected to be malignant;
Those who have no distant metastases;
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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing aerospace general hospital
Beijing, Beijing Municipality, 100076

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique

Read the 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.

Conditions: Pulmonary Nodule, Solitary
Being tested: Optimized Localization Technique
Keywords: Micro-coil, CT-guided locate
Medical subject headings: Solitary Pulmonary Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optimized Localization TechniqueProcedure or surgery
The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.

Study groups in NCT03649906
Study group	Role	What they receive
Optimized Localization Group	Experimental	Subjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative. Receives: Procedure: Optimized Localization Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of patients with pneumothorax.
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.
Measured: half an hour after positioning

Secondary outcomes (4)

Positioning success rate
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.
Measured: thoracoscopic surgery
Operation time
The time interval from the first scan to the last scan to confirm that the micro coil is left in place
Measured: At the end of the positioning operation
Number of operators
Number of people involved in the positioning operation
Measured: At the end of the positioning operation
Proportion of patients with complications other than pneumothorax
Measured: thoracoscopic surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201815 Jun 2021

First posted28 Aug 2018
Study start1 Sep 2018
Primary completion15 Jun 2021
Study completion15 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03649906
Sponsor's protocol ID: Z181100001718055
Status last verified: Jun 2021
First submitted: 26 Aug 2018
Last updated: 16 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Our hospital medical ethics committee does not allow us to share patients personal data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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European Real-World Registry for Use of the Ion Endoluminal System
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Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
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Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
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Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
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All Pulmonary Nodule, Solitary trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique
ClinicalTrials.gov ID: NCT03649906
Acronym / sponsor ID: Z181100001718055
Conditions: Pulmonary Nodule, Solitary
Keywords: Micro-coil, CT-guided locate
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Beijing Aerospace General HospitalUniversity, hospital or other
Study start: 1 Sep 2018 (actual)
Primary completion: 15 Jun 2021 (actual)
Study completion: 15 Jun 2021 (actual)
First posted: 28 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Optimized Localization Group	Experimental	Procedure: Optimized Localization TechniqueSubjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients between 18 years old (including 18 years old) and 85 years old (including 85 years old);
The nodule is clinically suspected to be malignant;
Those who have no distant metastases;
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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Optimized Localization TechniqueThe small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.	Procedure or surgery	Optimized Localization Group

Primary outcome

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.

4 secondary outcomes

Positioning success rate
Time frame: thoracoscopic surgery
Operation time
Time frame: At the end of the positioning operation
Number of operators
Time frame: At the end of the positioning operation
Proportion of patients with complications other than pneumothorax
Time frame: thoracoscopic surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
Individual participant dataSharing planned: No. Our hospital medical ethics committee does not allow us to share patients personal data.

Related trials for Pulmonary Nodule, Solitary

RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

li fengwei, MD principal investigator

Beijing Aerospace General Hospital Thoracic surgery department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Optimized Localization Technique in people with Pulmonary Nodule, Solitary, run by Beijing Aerospace General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with pneumothorax. (time frame: half an hour after positioning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.