GISTNCT01768325
Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)
A study testing EUS-Guided biopsy needle (ProCore) in people with GIST, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder. This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST
- What is being tested?
- EUS-Guided biopsy needle (ProCore)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Solid tumors ≥ 2 cm in size.
Who cannot join
- Thrombocytopenia
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202-5121
About this study
Official title: Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.
This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.
Read the detailed description
Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)
Secondary Objective To compare
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
- Conditions
- GIST
- Being tested
- EUS-TCB needle (QuickCore) standard of care, EUS-Guided biopsy needle (ProCore)
- Keywords
- ProCore Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-TCB needle (QuickCore) standard of careDevice
Also called Comparison of core biopsy needles.
- The number of needle passes requiring to acquire adequate specimen were tallied.
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
EUS-Guided biopsy needle (ProCore)Device
Also called Comparison of core biopsy needles.
- The number of needle passes requiring to acquire adequate specimen were tallied.
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
| Study group | Role | What they receive |
|---|---|---|
| EUS-Guided biopsy needle (ProCore) | Active comparator | Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle.
* The number of needle passes requiring to acquire adequate specimen
* Length of core tissue obtained
* Diagnostic contribution of immunohistochemical staining
* Rates of complications Receives: Device: EUS-Guided biopsy needle (ProCore) |
| EUS-TCB needle (Quick-Core) | Active comparator | Comparison of core biopsy needles.
* The number of needle passes requiring to acquire adequate specimen
* Length of core tissue obtained
* Diagnostic contribution of immunohistochemical staining
* Rates of complications Receives: Device: EUS-TCB needle (QuickCore) standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy.
Measured: 36 months
Secondary outcomes (2)
Overall Specimen Length
Measured: 36 months
Number of Needle Passes
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GISTStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M. DeWitt, M.D., Principal investigator, Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768325
- Sponsor's protocol ID
- 1104-03
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2013
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
- ClinicalTrials.gov ID
- NCT01768325
- Acronym / sponsor ID
- 1104-03
- Conditions
- GIST
- Keywords
- ProCore Needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 15 Dec 2015
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 evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.
This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.
Detailed description
Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)
Secondary Objective To compare
- The number of needle passes requiring to acquire adequate specimen
- Length of core tissue obtained
- Diagnostic contribution of immunohistochemical staining
- Rates of complications
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-Guided biopsy needle (ProCore) | Active comparator | Device: EUS-Guided biopsy needle (ProCore)Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications |
| EUS-TCB needle (Quick-Core) | Active comparator | Device: EUS-TCB needle (QuickCore) standard of careComparison of core biopsy needles. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Solid tumors ≥ 2 cm in size.
Key exclusion criteria (1 listed)
- Thrombocytopenia
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 |
|---|---|---|
| EUS-TCB needle (QuickCore) standard of careAlso: Comparison of core biopsy needles.* The number of needle passes requiring to acquire adequate specimen were tallied. * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications | Device | EUS-TCB needle (Quick-Core) |
| EUS-Guided biopsy needle (ProCore)Also: Comparison of core biopsy needles.* The number of needle passes requiring to acquire adequate specimen were tallied. * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications | Device | EUS-Guided biopsy needle (ProCore) |
Primary outcome
Diagnostic Accuracy.
Time frame: 36 months
2 secondary outcomes
Overall Specimen Length
Time frame: 36 months
Number of Needle Passes
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John M. DeWitt, M.D. principal investigator
Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-Guided biopsy needle (ProCore) in people with GIST, run by Indiana University at 1 site 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 1 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 29 Mar 2017. 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 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?
Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy. (time frame: 36 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 29 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.