Lung DiseaseNCT00817167
Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy
A study testing inReach bronchoscopy planning software and Standard lung CT viewer in people with Lung Disease, run by superDimension Ltd. at 1 site in Israel.
Trial summary
The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- inReach bronchoscopy planning software and Standard lung CT viewer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2009
- 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
- Candidates for non-emergency bronchoscopy
- Must provide signed informed consent
- Male or female above 18 years old
- Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope
Who cannot join
- CT done over a month before the bronchoscopy procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.
The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.
- Conditions
- Lung Disease
- Being tested
- inReach bronchoscopy planning software, Standard lung CT viewer
- Keywords
- Known or suspected lung disease, Candidates for non-emergency bronchoscopy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inReach bronchoscopy planning softwareDevice
inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.
Standard lung CT viewerDevice
CT viewer, used for standard bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| inReach (A) | Experimental | Bronchoscopy procedure is planned using inReach planning software Receives: Device: inReach bronchoscopy planning software |
| Control (B) | Active comparator | Bronchoscopy procedure is planned using standard CT viewer software Receives: Device: Standard lung CT viewer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures.
Measured: Until the definitive diagnosis is obtained
Secondary outcomes (1)
Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.
Measured: At discharge from bronchoscopy unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- superDimension Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avi Mann, MD, Principal investigator, Pulmonology Department, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817167
- Sponsor's protocol ID
- DPR0006
- Status last verified
- Nov 2014
- First submitted
- 1 Jan 2009
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.
PubMed 16608948Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.
PubMed 16873767Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.
PubMed 17400670
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.
- ClinicalTrials.gov ID
- NCT00817167
- Acronym / sponsor ID
- DPR0006
- Conditions
- Lung Disease
- Keywords
- Known or suspected lung disease, Candidates for non-emergency bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- superDimension Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Jan 2009 (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.
The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inReach (A) | Experimental | Device: inReach bronchoscopy planning softwareBronchoscopy procedure is planned using inReach planning software |
| Control (B) | Active comparator | Device: Standard lung CT viewerBronchoscopy procedure is planned using standard CT viewer software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidates for non-emergency bronchoscopy
- Must provide signed informed consent
- Male or female above 18 years old
- Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope
Key exclusion criteria (1 listed)
- CT done over a month before the bronchoscopy procedure
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 |
|---|---|---|
| inReach bronchoscopy planning softwareinReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually. | Device | inReach (A) |
| Standard lung CT viewerCT viewer, used for standard bronchoscopy | Device | Control (B) |
Primary outcome
Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures.
Time frame: Until the definitive diagnosis is obtained
1 secondary outcome
Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.
Time frame: At discharge from bronchoscopy unit
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 19 Nov 2014.
- Background: PubMed 16608948Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.
- Background: PubMed 16873767Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.
- Background: PubMed 17400670Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.
- superDimension Inc.Link provided by the sponsor.
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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.
Avi Mann, MD principal investigator
Pulmonology Department, Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inReach bronchoscopy planning software and Standard lung CT viewer in people with Lung Disease, run by superDimension Ltd. at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 19 Nov 2014. 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 Israel. 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?
Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures. (time frame: Until the definitive diagnosis is obtained). 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 NCT00817167, which also lists 3 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 19 Nov 2014.