Lung CancerPhase 2NCT01145924
Transbronchial Needle Forceps for Endobronchial Ultrasound
A Phase 2 study testing EBUS TBNF in people with Lung Cancer and Lymph Nodes, run by Heidelberg University at 1 site in Germany.
Trial summary
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Lymph Nodes
- What is being tested?
- EBUS TBNF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enlarged mediastinal lymph nodes
Who cannot join
- comorbidities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik
Heidelberg, 69126
Ralf Eberhardt, MD, +49 6221 396 ext. 8204, Ralf.Eberhardt@thoraxklinik-heidelberg.de
Ralf Eberhardt, MD
About this study
Official title: Transbronchial Needle Forceps for EBUS
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes
Read the detailed description
Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often
- Conditions
- Lung Cancer, Lymph Nodes
- Being tested
- EBUS TBNF
- Keywords
- bronchoscopy, endobronchial ultrasound, transbronchial needle aspiration, lung cancer, staging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS TBNFProcedure or surgery
Also called Endobronchial ultrasound
Transbronchial needle forceps will be use with the EBUS TBNA scope
| Study group | Role | What they receive |
|---|---|---|
| EBUS TBNF | Active comparator | single arm trial, patients with enlarged mediastinal nodes will be examine Receives: Procedure: EBUS TBNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a positive biopsy result
Measured: 2 days after intervention
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Hendrik Dienemann, PhD, MD, Study director, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145924
- Sponsor's protocol ID
- HD 08
- Status last verified
- Feb 2010
- First submitted
- 7 Jun 2010
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herth FJ, Schuler H, Gompelmann D, Kahn N, Gasparini S, Ernst A, Schuhmann M, Eberhardt R. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. Eur Respir J. 2012 Feb;39(2):373-7. doi: 10.1183/09031936.00033311. Epub 2011 Jun 23.
PubMed 21700609
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Needle Forceps for EBUS
- ClinicalTrials.gov ID
- NCT01145924
- Acronym / sponsor ID
- HD 08
- Conditions
- Lung Cancer, Lymph Nodes
- Keywords
- bronchoscopy, endobronchial ultrasound, transbronchial needle aspiration, lung cancer, staging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 17 Jun 2010 (estimated)
- 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.
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes
Detailed description
Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS TBNF | Active comparator | Procedure: EBUS TBNFsingle arm trial, patients with enlarged mediastinal nodes will be examine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- enlarged mediastinal lymph nodes
Key exclusion criteria (1 listed)
- comorbidities
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 |
|---|---|---|
| EBUS TBNFAlso: Endobronchial ultrasoundTransbronchial needle forceps will be use with the EBUS TBNA scope | Procedure or surgery | EBUS TBNF |
Primary outcome
Number of Participants with a positive biopsy result
Time frame: 2 days after intervention
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2010.
- Derived from this study: PubMed 21700609Herth FJ, Schuler H, Gompelmann D, Kahn N, Gasparini S, Ernst A, Schuhmann M, Eberhardt R. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. Eur Respir J. 2012 Feb;39(2):373-7. doi: 10.1183/09031936.00033311. Epub 2011 Jun 23.
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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.
Hendrik Dienemann, PhD, MD study director
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EBUS TBNF in people with Lung Cancer and Lymph Nodes, run by Heidelberg University at 1 site in Germany.
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 17 Jun 2010. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Felix JF Herth, PhD, MD (+49 6221 396 ext. 1200, Felix.Herth@thoraxklinik-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a positive biopsy result (time frame: 2 days after intervention). 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 NCT01145924, which also lists 1 linked publication.
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 17 Jun 2010.