Quantity of Tissue ObtainedNCT02154698
22-gauge ProCore Needle v. Standard 22-gauge (P00030500)
A study testing 22-gauge Standard Needle and 22-gauge ProCore Needle in people with Quantity of Tissue Obtained and Quality of Tissue Obtained, run by Medical University of South Carolina at 4 sites in United States.
Trial summary
The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quantity of Tissue Obtained, Quality of Tissue Obtained, Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
- What is being tested?
- 22-gauge Standard Needle and 22-gauge ProCore Needle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2014to 19 Dec 2017
- 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
- Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity.
- Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview.
Who cannot join
- Subjects who refuse to participate, or demonstrate inability to give informed consent
- Subjects who are less than 18 years of age
- Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
- Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland
University of North Carolina Medical School
Chapel Hill, North Carolina
Medical University of South Carolina
Charleston, South Carolina
University of Florida
Gainesville, Florida, 32611
About this study
Official title: A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound
The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound
Read the detailed description
The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful.
The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.
- Conditions
- Quantity of Tissue Obtained, Quality of Tissue Obtained, Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
- Being tested
- 22-gauge Standard Needle, 22-gauge ProCore Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22-gauge Standard NeedleOther
Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
22-gauge ProCore NeedleOther
Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
| Study group | Role | What they receive |
|---|---|---|
| 22-gauge Standard Needle | Active comparator | Participants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes) Receives: Other: 22-gauge Standard Needle |
| 22-gauge ProCore Needle | Active comparator | Participants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes) Receives: Other: 22-gauge ProCore Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.
Measured: Within two weeks from the day of the procedure
Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
Measured: Within two weeks from the day of the procedure
Quantity of tissue obtained (measured by number of unstructured fragments)
Measured: Within two weeks from the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quantity of Tissue ObtainedStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Endoscopy, University of North Carolina, Johns Hopkins University, Thoraxklinik-Heidelberg gGmbH
- Responsible party
- Sponsor
- Investigators
- Nichole T Tanner, MD, M.S.C.R, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154698
- Sponsor's protocol ID
- 00030500
- Status last verified
- Apr 2018
- First submitted
- 22 May 2014
- Last updated
- 30 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound
- ClinicalTrials.gov ID
- NCT02154698
- Acronym / sponsor ID
- 00030500
- Conditions
- Quantity of Tissue Obtained, Quality of Tissue Obtained, Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Cook Endoscopy, University of North Carolina, Johns Hopkins University, Thoraxklinik-Heidelberg gGmbH
- Study start
- Jun 2014
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 3 Jun 2014 (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 compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound
Detailed description
The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful.
The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22-gauge Standard Needle | Active comparator | Other: 22-gauge Standard NeedleParticipants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes) |
| 22-gauge ProCore Needle | Active comparator | Other: 22-gauge ProCore NeedleParticipants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity.
- Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview.
Key exclusion criteria (5 listed)
- Subjects who refuse to participate, or demonstrate inability to give informed consent
- Subjects who are less than 18 years of age
- Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
- Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
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 |
|---|---|---|
| 22-gauge Standard NeedleAcquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway. | Other | 22-gauge Standard Needle |
| 22-gauge ProCore NeedleAcquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway. | Other | 22-gauge ProCore Needle |
Primary outcome
Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.
Time frame: Within two weeks from the day of the procedure
Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
Time frame: Within two weeks from the day of the procedure
Quantity of tissue obtained (measured by number of unstructured fragments)
Time frame: Within two weeks from the day of the procedure
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 30 Apr 2018.
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.
Nichole T Tanner, MD, M.S.C.R principal investigator
Medical University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 22-gauge Standard Needle and 22-gauge ProCore Needle in people with Quantity of Tissue Obtained and Quality of Tissue Obtained, run by Medical University of South Carolina at 4 sites in United States.
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 5 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles. (time frame: Within two weeks from the day of the procedure). The study lists 3 primary outcomes in all. 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 30 Apr 2018.