Lung CancerNCT01947530
Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules
A study testing Navigational Bronchoscopy and Standard Bronchoscopy in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Navigational Bronchoscopy and Standard Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to 24 May 2019
- 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
- Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.
Who cannot join
- Pulmonary nodules less than 1.0 cm
- patients must be able to tolerate general anesthesia
- patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal
- patients unable to tolerate bronchoscopy
- pregnant patients or patients who believe they are pregnant
- patients with implantable devices susceptible to Radio Frequency (RF) fields
- severely obese patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
- Conditions
- Lung Cancer
- Being tested
- Navigational Bronchoscopy, Standard Bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigational BronchoscopyProcedure or surgery
Also called 4-D EM Tip-tracked Devices, Veran Navigational System
Standard BronchoscopyProcedure or surgery
Also called Standard Bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| Navigational Bronch/Standard Bronch | Active comparator | Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed. Receives: Procedure: Navigational Bronchoscopy; Procedure: Standard Bronchoscopy |
| Standard Bronch/Navigational Bronch | Active comparator | Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed. Receives: Procedure: Navigational Bronchoscopy; Procedure: Standard Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure.
Measured: up to 1 year
Secondary outcomes (3)
Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules
Measured: up to 1 year
Total virtual bronchoscopy time
Information will be gathered at time of procedure
Measured: Day 1
Total procedure time
This information will be gathered at the time of procedure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Yasufuku, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947530
- Sponsor's protocol ID
- 12-5056-B
- Status last verified
- Mar 2020
- First submitted
- 6 Sep 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT01947530
- Acronym / sponsor ID
- 12-5056-B
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 20 Sep 2013 (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 purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigational Bronch/Standard Bronch | Active comparator | Procedure: Navigational Bronchoscopy, Procedure: Standard BronchoscopyPatient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed. |
| Standard Bronch/Navigational Bronch | Active comparator | Procedure: Navigational Bronchoscopy, Procedure: Standard BronchoscopyPatient will first have a standard bronchoscopy then a navigational bronchoscopy completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.
Key exclusion criteria (7 listed)
- Pulmonary nodules less than 1.0 cm
- patients must be able to tolerate general anesthesia
- patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal
- patients unable to tolerate bronchoscopy
- pregnant patients or patients who believe they are pregnant
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 |
|---|---|---|
| Navigational BronchoscopyAlso: 4-D EM Tip-tracked Devices, Veran Navigational System | Procedure or surgery | Navigational Bronch/Standard Bronch, Standard Bronch/Navigational Bronch |
| Standard BronchoscopyAlso: Standard Bronchoscope | Procedure or surgery | Navigational Bronch/Standard Bronch, Standard Bronch/Navigational Bronch |
Primary outcome
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
Time frame: up to 1 year
This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure.
3 secondary outcomes
Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules
Time frame: up to 1 year
Total virtual bronchoscopy time
Time frame: Day 1
Total procedure time
Time frame: Day 1
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 25 Mar 2020.
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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.
Kazuhiro Yasufuku, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigational Bronchoscopy and Standard Bronchoscopy in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 7 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 25 Mar 2020. 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 Canada. 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?
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.