Endobronchial Transbronchial Needle Aspiration Lung Cancer ProcoreNCT02931461
Interest of Procore Needle® for Diagnosis of Lung Cancer
A study testing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in people with Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore, run by Poitiers University Hospital.
Trial summary
The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
- What is being tested?
- Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2016to 16 Jul 2018
- 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
- mediastinal lymphadenopathy >10 millimeters
- lung cancer suspected
Who cannot join
- coagulopathy contraindication for midazolam contraindication for bronchoscopy
About this study
The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.
- Being tested
- Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
- Keywords
- endobronchial transbronchial needle aspiration lung cancer procore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial Ultrasound-Guided Transbronchial Needle AspirationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| needle Procore ® | Experimental | Not described Receives: Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration |
| needle Cook® | Active comparator | Not described Receives: Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of histological diagnoses for each needle
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start27 Oct 2016
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial Transbronchial Needle Aspiration Lung Cancer ProcoreStudies of the same condition, open and under way.
- More trials run by Poitiers University 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
- Other
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931461
- Sponsor's protocol ID
- PR-EBUS
- Status last verified
- May 2020
- First submitted
- 7 Sep 2016
- Last updated
- 2 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Procore Needle® for Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT02931461
- Acronym / sponsor ID
- PR-EBUS
- Keywords
- endobronchial transbronchial needle aspiration lung cancer procore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 13 Oct 2016 (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 ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.
Study design
- Primary purpose
- Other
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needle Procore ® | Experimental | Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration |
| needle Cook® | Active comparator | Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mediastinal lymphadenopathy >10 millimeters
- lung cancer suspected
Key exclusion criteria (1 listed)
- coagulopathy contraindication for midazolam contraindication for bronchoscopy
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 |
|---|---|---|
| Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration | Procedure or surgery | needle Cook®, needle Procore ® |
Primary outcome
Proportion of histological diagnoses for each needle
Time frame: 6 months
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 2 Jun 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in people with Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore, run by Poitiers University Hospital.
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 2 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of histological diagnoses for each needle (time frame: 6 months). 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 2 Jun 2020.