Transbronchial Lung Biopsy Guided by ENB

NCT03628222 | Completed

• 1 other identifier: LHCTP001
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .

Conditions

Lung Lesion(s) Requiring Evaluation

Keywords

Lung lesion; Electromagnetic navigation bronchoscopy (ENB); Transbronchial lung biopsy(TBLB); bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB

  Diagnostic yield = Lesions with definitive diagnosis /total lesions with biopsies. Comment: Lesions with definitive diagnosis: 1. Biopsy pathologic results show as benign or malignant lesion (fungi, tuberculosis, or nodule disease,etc.); 2. Biopsy pathologic results are abnormal lung tissue, but through later diagnosis, treatment and other observation measures, the lesion is proved to be benign; 3. When the patient cannot be diagnosed after a 6-month following-up, a CT or enhanced CT scan is needed and the physician make a final diagnosis based on the scan results.

  Up to 6 months

Secondary Outcomes (5)

• Incidence of navigation success

  At 1 day of ENB procedure

• Lesion detection rate

  About 3-7days after ENB or X-ray procedure

• Navigation time

  At 1 day of ENB or X-ray procedure

• Evaluate the user satisfaction of ENB system and system kit

  At 1 day of ENB procedure

• The adverse events and device defects related to the ENB system and system kit

  Up to 3 days

Study Arms (2)

ENB-TBLB

EXPERIMENTAL

Under ENB guidance, the Location Catheter and Guide Catheter reach the lesion. After confirmation by X-ray, biopsy tools are introduced and specimens are obtained.

Device: ENB-TBLB

X-ray-TBLB

ACTIVE COMPARATOR

Based on chest CT, the physician determines the lesion location. Under X-ray guidance, via the bronchoscope's working channel, the biopsy forceps and brush are introduced and specimens are obtained.

Device: X-ray-TBLB

Interventions

ENB-TBLB DEVICE

ENB Guidance: The iLungTM SuperNavigator system will be used, it comprises of iLungTM ENB system, location catheter and guide catheter. The guide catheter can supply a 1.9 mm working channel for biopsy tools. The location catheter is inserted into the guide catheter beforehand, then both are introduced via the working channel of the bronchoscope. Under guidance of ENB system, the location catheter reaches the lesion, and actual distance is confirmed by the X-ray. TBLB: Location catheter is retracted, then the biopsy forceps and brush was introduced, and pathologic specimens are obtained.

ENB-TBLB

X-ray-TBLB DEVICE

Based on chest CT, the physician determines the lesion location. Under X-ray guidance, via the bronchoscope's working channel, the biopsy forceps and brush are introduced and pathologic specimens are obtained.

X-ray-TBLB

Eligibility Criteria

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

You may qualify if:

• years and older;
• Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is needed;
• Subject is willing to receive bronchoscopy voluntarily, and meets relevant requirements;
• Subject or their guardian understands the purpose of this trial, and willing to participate in the trial voluntarily and sign Informed Consent Form (ICF).

You may not qualify if:

• Subject has participated in a drug or device study (drug study within 3 months or device study within 1 month);
• Female subject who is pregnant or nursing;
• Allergic to anesthetic;
• Bronchoscopy contraindications, include: Active hemoptysis; Newly developed myocardial infarction or unstable angina attack; Severe cardiac and pulmonary dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension, etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm; Multiple lung bullae; Extremely exhausted systemic conditions;
• Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema, etc) ,which investigator considers not appropriate for this examination;
• Subject with implanted pacemaker or defibrillator;
• Lack of patient cooperation for bronchoscopy, such as patient with mental disorders, dysgnosia, psychological disorder etc;
• Conditions investigator considers not appropriate for this trial.

Sponsors & Collaborators

• Changzhou LungHealth Medtech Company Limited: lead

Study Sites (8)

Cancer Hospital, Chinese Academy of Medical sciences

Beijing, Beijing Municipality, 100021, China

Location

The second affiliated hospital, Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

The First Affiliate Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

The first affiliated hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

Location

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

The first affiliated hospital, Zhejiang university

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (4)

• Mahajan AK, Patel S, Hogarth DK, Wightman R. Electromagnetic navigational bronchoscopy: an effective and safe approach to diagnose peripheral lung lesions unreachable by conventional bronchoscopy in high-risk patients. J Bronchology Interv Pulmonol. 2011 Apr;18(2):133-7. doi: 10.1097/LBR.0b013e318216cee6.

  PMID: 23169081 BACKGROUND

• Mukherjee S, Chacey M. Diagnostic Yield of Electromagnetic Navigation Bronchoscopy Using a Curved-tip Catheter to Aid in the Diagnosis of Pulmonary Lesions. J Bronchology Interv Pulmonol. 2017 Jan;24(1):35-39. doi: 10.1097/LBR.0000000000000326.

  PMID: 27623421 BACKGROUND

• Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3.

  PMID: 22391437 BACKGROUND

• Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.

  PMID: 23649436 BACKGROUND

Study Officials

• Shiyue Li

  The First Affiliate Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 14, 2018
• Study Start: January 4, 2019
• Primary Completion: July 30, 2020
• Study Completion: August 10, 2020
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)