Yield of Cryo Biopsy in Lung CancerNCT01221493
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
A study testing Cryo biopsy in people with Yield of Cryo Biopsy in Lung Cancer and Solitary Pulmonary Nodule, run by Heidelberg University at 1 site in Germany.
Trial summary
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Yield of Cryo Biopsy in Lung Cancer, Solitary Pulmonary Nodule
- What is being tested?
- Cryo biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2010
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- solitary pulmonary nodule < 4 cm
- no endobronchial lesion
- indication for bronchoscopy
Who cannot join
- coagulopathy
- pulmonary hypertension
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Pneumology and Critical Care medicine
Heidelberg, Baden-Wurttemberg, 69190
Felix JF Herth, MD, PhD, +49 6221 396 ext. 1200, felix.herth@thoraxklinik-heidelberg.de
Felix JF Herth, MD, Phd
About this study
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Read the detailed description
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.
Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.
- Being tested
- Cryo biopsy
- Keywords
- solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo biopsyProcedure or surgery
Also called Cryo biopsy probe 20416-032, ERBE company, Germany
Cryoprobe, Erbe Company
| Study group | Role | What they receive |
|---|---|---|
| Cryo biospy | Experimental | Not described Receives: Procedure: Cryo biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication
Measured: 24 h after intervention
Secondary outcomes (1)
Efficacy
Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion
Measured: 48 h after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Yield of Cryo Biopsy in 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Felix JF Herth, MD, PhD, Principal investigator, Thoraxklinik, Universityof Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221493
- Sponsor's protocol ID
- S-320
- Status last verified
- Mar 2010
- First submitted
- 14 Oct 2010
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.
PubMed 20802352Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.
PubMed 20477337Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. doi: 10.1159/000232394. Epub 2009 Jul 31.
PubMed 19648733Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10.
PubMed 20203535Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
PubMed 23900983
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT01221493
- Acronym / sponsor ID
- S-320
- Keywords
- solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Oct 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.
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Detailed description
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.
Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryo biospy | Experimental | Procedure: Cryo biopsy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- solitary pulmonary nodule < 4 cm
- no endobronchial lesion
- indication for bronchoscopy
Key exclusion criteria (3 listed)
- coagulopathy
- pulmonary hypertension
- pregnancy
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 |
|---|---|---|
| Cryo biopsyAlso: Cryo biopsy probe 20416-032, ERBE company, GermanyCryoprobe, Erbe Company | Procedure or surgery | Cryo biospy |
Primary outcome
Safety
Time frame: 24 h after intervention
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication
1 secondary outcome
Efficacy
Time frame: 48 h after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
- Background: PubMed 20802352Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.
- Background: PubMed 20477337Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.
- Background: PubMed 19648733Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. doi: 10.1159/000232394. Epub 2009 Jul 31.
- Background: PubMed 20203535Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10.
- Derived from this study: PubMed 23900983Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
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.
Felix JF Herth, MD, PhD principal investigator
Thoraxklinik, Universityof Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo biopsy in people with Yield of Cryo Biopsy in Lung Cancer and Solitary Pulmonary Nodule, 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 3 inclusion and 3 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 15 Oct 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.
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, MD, PhD (+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?
Safety (time frame: 24 h 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 NCT01221493, which also lists 5 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 15 Oct 2010.