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

NCT03649906 | Completed DMC

• 1 other identifier: Z181100001718055
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule, Solitary

Keywords

Micro-coil; CT-guided locate

Outcome Measures

Primary Outcomes (1)

• 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.

  half an hour after positioning

Secondary Outcomes (4)

• Positioning success rate

  thoracoscopic surgery

• Operation time

  At the end of the positioning operation

• Number of operators

  At the end of the positioning operation

• Proportion of patients with complications other than pneumothorax

  thoracoscopic surgery

Study Arms (1)

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.

Procedure: Optimized Localization Technique

Interventions

Optimized Localization Technique PROCEDURE

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

Optimized Localization Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Aerospace General Hospital: lead

Study Sites (1)

Beijing aerospace general hospital

Beijing, Beijing Municipality, 100076, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• li fengwei, MD

  Beijing Aerospace General Hospital Thoracic surgery department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: August 28, 2018
• Study Start: September 1, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)