Lung Lesion(s) Requiring EvaluationNCT03628222

Transbronchial Lung Biopsy Guided by ENB

A study testing ENB-TBLB and X-ray-TBLB in people with Lung Lesion(s) Requiring Evaluation, run by Changzhou LungHealth Medtech Company Limited at 8 sites 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

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Lesion(s) Requiring Evaluation
What is being tested?: ENB-TBLB and X-ray-TBLB
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 226 participants
Where: 8 sitesChina
Study dates: 4 Jan 2019to 10 Aug 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 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).

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

Cancer Hospital, Chinese Academy of Medical sciences
Beijing, Beijing Municipality, 100021
West China Hospital
Chengdu, Sichuan, 610041
The First Affiliate Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
The first affiliated hospital, Zhejiang university
Hangzhou, Zhejiang, 310003
The second affiliated hospital, Fujian Medical University
Quanzhou, Fujian, 362000
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
The first affiliated hospital of Suzhou University
Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study

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

Read the detailed description

This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance.

Conditions: Lung Lesion(s) Requiring Evaluation
Being tested: ENB-TBLB, X-ray-TBLB
Keywords: Lung lesion, Electromagnetic navigation bronchoscopy (ENB), Transbronchial lung biopsy(TBLB), bronchoscopy

What participants receive

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

ENB-TBLBDevice
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.
X-ray-TBLBDevice
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.

Study groups in NCT03628222
Study group	Role	What they receive
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. Receives: 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. Receives: Device: X-ray-TBLB

What is being measured

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

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.
Measured: Up to 6 months

Secondary outcomes (5)

Incidence of navigation success
This outcome just apply to experimental group. Incidence of navigation success = the number of lesions navigated successfully/total lesions with ENB procedure × 100%.
Criteria for navigation success: When the navigation software shows the distance of location sensor to the target ≤10mm, using X-ray to confirm the actual distance, if the physician determine that biopsy can be conducted, the navigation is successful, if not, the navigation fails.
Measured: At 1 day of ENB procedure
Lesion detection rate
Based on the biopsy pathologic results, evaluate the lesion detection rate of experimental and control group.
Lesion detection rate = Total lesions detected / Total lesions with biopsies. Comment: 'Lesions detected' indicates pathologic result shows as abnormal lung tissue.
Measured: About 3-7days after ENB or X-ray procedure
Navigation time
Evaluate navigation time of experimental and control group. Experimental group: After registration, the location sensor returns the carina. Navigation begins from the carina and ends when the sensor reaches the edge of the lesion, which is verified by the X-ray. This period is defined as navigation time of experimental group.
Control group: Under X-ray guidance, the bronchoscope moves from the carina to the edge of the lesion. This period is defined as navigation time of control group.
Measured: At 1 day of ENB or X-ray procedure
Evaluate the user satisfaction of ENB system and system kit
After each ENB procedure, the investigator evaluate the operational performance of ENB system and system kit through a pre-designed questionnaire which includes terms related to the device function, convenience, reliability and safety.
Measured: At 1 day of ENB procedure
The adverse events and device defects related to the ENB system and system kit
Adverse events: Include incidence of pneumothorax, bleeding, respiratory failure, etc.
Measured: Up to 3 days

Timeline

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

4 Jan 201910 Aug 2020

First posted14 Aug 2018
Study start4 Jan 2019
Primary completion30 Jul 2020
Study completion10 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Lung Lesion(s) Requiring EvaluationStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03628222
Sponsor's protocol ID: LHCTP001
Status last verified: Aug 2024
First submitted: 23 Jul 2018
Last updated: 23 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23169081
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.
PubMed 27623421
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.
PubMed 22391437
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.
PubMed 23649436

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study
ClinicalTrials.gov ID: NCT03628222
Acronym / sponsor ID: LHCTP001
Conditions: Lung Lesion(s) Requiring Evaluation
Keywords: Lung lesion, Electromagnetic navigation bronchoscopy (ENB), Transbronchial lung biopsy(TBLB), bronchoscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: Changzhou LungHealth Medtech Company LimitedIndustry (pharma, biotech, devices)
Study start: 4 Jan 2019 (actual)
Primary completion: 30 Jul 2020 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 14 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.

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ENB-TBLB	Experimental	Device: ENB-TBLBUnder ENB guidance, the Location Catheter and Guide Catheter reach the lesion. After confirmation by X-ray, biopsy tools are introduced and specimens are obtained.
X-ray-TBLB	Active comparator	Device: X-ray-TBLBBased 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.

Who may qualify

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

Key inclusion criteria (4 listed)

18 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).

Key exclusion criteria (8 listed)

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;

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
ENB-TBLBENB 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.	Device	ENB-TBLB
X-ray-TBLBBased 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.	Device	X-ray-TBLB

Primary outcome

Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
Time frame: Up to 6 months
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.

5 secondary outcomes

Incidence of navigation success
Time frame: At 1 day of ENB procedure
Lesion detection rate
Time frame: About 3-7days after ENB or X-ray procedure
Navigation time
Time frame: At 1 day of ENB or X-ray procedure
Evaluate the user satisfaction of ENB system and system kit
Time frame: At 1 day of ENB procedure
The adverse events and device defects related to the ENB system and system kit
Time frame: Up to 3 days

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 23 Aug 2024.
Background: PubMed 23169081Mahajan 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.
Background: PubMed 27623421Mukherjee 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.
Background: PubMed 22391437Lamprecht 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.
Background: PubMed 23649436Rivera 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.
Individual participant dataSharing planned: No

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.

Shiyue Li principal investigator

The First Affiliate Hospital of Guangzhou Medical University

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

Questions about this trial

What is this clinical trial studying?

A study testing ENB-TBLB and X-ray-TBLB in people with Lung Lesion(s) Requiring Evaluation, run by Changzhou LungHealth Medtech Company Limited at 8 sites 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 8 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB (time frame: Up to 6 months). 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 NCT03628222, which also lists 4 linked publications.

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 23 Aug 2024.