Lung CancerNCT05110131
Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy
A study testing Device for performing biopsy via electromagnetic navigation bronchoscopy in people with Lung Cancer and Lung Cancer (Diagnosis), run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Cancer (Diagnosis)
- What is being tested?
- Device for performing biopsy via electromagnetic navigation bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2021to 13 Nov 2024
- 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
- Patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for ENB procedure under moderate sedation
Who cannot join
- Patients who disagree to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy
This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.
Read the detailed description
This randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (ENB)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions.
The investigators designed this study to prospectively enroll patients with lung lesions that warrant histologic diagnosis and are feasible for undergoing electromagnetic bronchoscopy under moderate sedation. Participants will be randomized to two groups. One group will receive an ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-first group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-first group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy and radial endobronchial sonography. All participants will be followed up for up to 12 months to confirm the final diagnosis.
The primary endpoint is the diagnostic accuracy of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with forceps biopsy alone. Diagnostic accuracy was defined as the proportion of participants in whom the biopsy yielded a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management (true negative) without the change in diagnosis through 12 months of follow-up.
Secondary endpoints include diagnostic accuracy of the combination compared with needle aspiration alone, sensitivity for malignancy, and the strictly defined diagnostic yield determined solely based on the ENB procedural encounter, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.
- Conditions
- Lung Cancer, Lung Cancer (Diagnosis)
- Being tested
- Device for performing biopsy via electromagnetic navigation bronchoscopy
- Keywords
- Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Diagnosis
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device for performing biopsy via electromagnetic navigation bronchoscopyDevice
Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)
| Study group | Role | What they receive |
|---|---|---|
| Needle-first | Active comparator | Participants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy Receives: Device: Device for performing biopsy via electromagnetic navigation bronchoscopy |
| Forceps-first | Active comparator | Participants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration. Receives: Device: Device for performing biopsy via electromagnetic navigation bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conservative diagnostic accuracy at 12 months
([True positive + True negative]/All biopsied performed)
Measured: Confirmed by follow-up results at 12 months
Secondary outcomes (3)
Sensitivity of needle or forceps biopsy for diagnosis of malignancy
True positive/Confirmed malignancy cases
Measured: Confirmed by follow-up results at 12 months
Diagnostic yield at index procedure
The proportion of pathologic results that leads to a specific malignant or benign diagnosis
Measured: At index procedure
Duration of procedure
Total duration and time per sampling for needle and forceps biopsy
Measured: At index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Dec 2021
- Primary completion13 Nov 2023
- Study completion13 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Wook Kim, Seoul National University Bundang Hospital
- Investigators
- Yeon Wook Kim, MD., PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110131
- Sponsor's protocol ID
- CONFIDENT_ENB
- Status last verified
- Jun 2024
- First submitted
- 14 Oct 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.
PubMed 30476574Vachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The Impact of Alternative Approaches to Diagnostic Yield Calculation in Studies of Bronchoscopy. Chest. 2022 May;161(5):1426-1428. doi: 10.1016/j.chest.2021.08.074. Epub 2021 Sep 7. No abstract available.
PubMed 34506792Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
PubMed 26367186Gildea TR, Folch EE, Khandhar SJ, Pritchett MA, LeMense GP, Linden PA, Arenberg DA, Rickman OB, Mahajan AK, Singh J, Cicenia J, Mehta AC, Lin H, Mattingley JS; NAVIGATE Study Investigators. The Impact of Biopsy Tool Choice and Rapid On-Site Evaluation on Diagnostic Accuracy for Malignant Lesions in the Prospective: Multicenter NAVIGATE Study. J Bronchology Interv Pulmonol. 2021 Jul 1;28(3):174-183. doi: 10.1097/LBR.0000000000000740.
PubMed 33369988Folch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.
PubMed 32450240Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12.
PubMed 27174878Kim YW, Kim HJ, Kwon BS, Lee YJ, Song MJ, Yoon SH, Lim SY, Lee YJ, Park JS, Cho YJ, Lee KH, Chung JH, Han YB, Maldonado F, Ahn SY, Park Y, Joo DH, Lee JH, Lee CT. Diagnostic Yield and Synergistic Impact of Needle Aspiration and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Controlled Trial. Chest. 2025 Jul;168(1):236-247. doi: 10.1016/j.chest.2025.02.015. Epub 2025 Feb 22.
PubMed 39993594Kim YW, Kim HJ, Yoon SH, Lee KH, Park YM, Ahn SY, Song MJ, Kwon BS, Lim SY, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee JH, Lee CT. Evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy: the CONFIDENT-ENB trial design. BMC Pulm Med. 2022 Aug 19;22(1):319. doi: 10.1186/s12890-022-02104-w.
PubMed 35986257
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy
- ClinicalTrials.gov ID
- NCT05110131
- Acronym / sponsor ID
- CONFIDENT_ENB
- Conditions
- Lung Cancer, Lung Cancer (Diagnosis)
- Keywords
- Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2024 (estimated)
- First posted
- 5 Nov 2021 (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.
This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.
Detailed description
This randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (ENB)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions.
The investigators designed this study to prospectively enroll patients with lung lesions that warrant histologic diagnosis and are feasible for undergoing electromagnetic bronchoscopy under moderate sedation. Participants will be randomized to two groups. One group will receive an ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-first group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-first group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy and radial endobronchial sonography. All participants will be followed up for up to 12 months to confirm the final diagnosis.
The primary endpoint is the diagnostic accuracy of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with forceps biopsy alone. Diagnostic accuracy was defined as the proportion of participants in whom the biopsy yielded a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management (true negative) without the change in diagnosis through 12 months of follow-up.
Secondary endpoints include diagnostic accuracy of the combination compared with needle aspiration alone, sensitivity for malignancy, and the strictly defined diagnostic yield determined solely based on the ENB procedural encounter, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Needle-first | Active comparator | Device: Device for performing biopsy via electromagnetic navigation bronchoscopyParticipants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy |
| Forceps-first | Active comparator | Device: Device for performing biopsy via electromagnetic navigation bronchoscopyParticipants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for ENB procedure under moderate sedation
Key exclusion criteria (1 listed)
- Patients who disagree to participate
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 |
|---|---|---|
| Device for performing biopsy via electromagnetic navigation bronchoscopyDevice for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps) | Device | Forceps-first, Needle-first |
Primary outcome
Conservative diagnostic accuracy at 12 months
Time frame: Confirmed by follow-up results at 12 months
([True positive + True negative]/All biopsied performed)
3 secondary outcomes
Sensitivity of needle or forceps biopsy for diagnosis of malignancy
Time frame: Confirmed by follow-up results at 12 months
Diagnostic yield at index procedure
Time frame: At index procedure
Duration of procedure
Time frame: At index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 30476574Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.
- Background: PubMed 34506792Vachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The Impact of Alternative Approaches to Diagnostic Yield Calculation in Studies of Bronchoscopy. Chest. 2022 May;161(5):1426-1428. doi: 10.1016/j.chest.2021.08.074. Epub 2021 Sep 7. No abstract available.
- Background: PubMed 26367186Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
- Background: PubMed 33369988Gildea TR, Folch EE, Khandhar SJ, Pritchett MA, LeMense GP, Linden PA, Arenberg DA, Rickman OB, Mahajan AK, Singh J, Cicenia J, Mehta AC, Lin H, Mattingley JS; NAVIGATE Study Investigators. The Impact of Biopsy Tool Choice and Rapid On-Site Evaluation on Diagnostic Accuracy for Malignant Lesions in the Prospective: Multicenter NAVIGATE Study. J Bronchology Interv Pulmonol. 2021 Jul 1;28(3):174-183. doi: 10.1097/LBR.0000000000000740.
- Background: PubMed 32450240Folch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.
- Background: PubMed 27174878Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12.
- Derived from this study: PubMed 39993594Kim YW, Kim HJ, Kwon BS, Lee YJ, Song MJ, Yoon SH, Lim SY, Lee YJ, Park JS, Cho YJ, Lee KH, Chung JH, Han YB, Maldonado F, Ahn SY, Park Y, Joo DH, Lee JH, Lee CT. Diagnostic Yield and Synergistic Impact of Needle Aspiration and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Controlled Trial. Chest. 2025 Jul;168(1):236-247. doi: 10.1016/j.chest.2025.02.015. Epub 2025 Feb 22.
- Derived from this study: PubMed 35986257Kim YW, Kim HJ, Yoon SH, Lee KH, Park YM, Ahn SY, Song MJ, Kwon BS, Lim SY, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee JH, Lee CT. Evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy: the CONFIDENT-ENB trial design. BMC Pulm Med. 2022 Aug 19;22(1):319. doi: 10.1186/s12890-022-02104-w.
- Individual participant dataSharing planned: No
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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.
Yeon Wook Kim, MD., PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device for performing biopsy via electromagnetic navigation bronchoscopy in people with Lung Cancer and Lung Cancer (Diagnosis), run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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 South Korea. 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?
Results are not available in the source record.
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?
Conservative diagnostic accuracy at 12 months (time frame: Confirmed by follow-up results at 12 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 NCT05110131, which also lists 8 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 11 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.