GI LesionsNCT03011229
Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule
A study testing Pro Core Needle and medtronic Sharkcore Needle in people with GI Lesions, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle. The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Lesions
- What is being tested?
- Pro Core Needle and medtronic Sharkcore Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to Sep 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
- Patients age 18 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
- Women that have a negative pregnant test
Who cannot join
- Patients under the age of 18.
- Uncorrectable coagulopathy (INR>1.5)
- Uncorrectable thrombocytopenia (platelet count <50,000)
- Patient who is unable to comply with study requirements
- Pregnant women
- Female patients who are not tested per our current unit protocol
- Refusal to consent or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study
The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.
The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.
- Conditions
- GI Lesions
- Being tested
- Pro Core Needle, medtronic Sharkcore Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Core NeedleDevice
Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
medtronic Sharkcore NeedleDevice
Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
| Study group | Role | What they receive |
|---|---|---|
| Pro Core | Active comparator | Subject is randomized to ProCore standard needle. Receives: Device: Pro Core Needle |
| Medtronic Shark Core | Experimental | Subject is randomized to Medtronic Sharkcore needle Receives: Device: medtronic Sharkcore Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of biopsy needle
Measured: end of biopsy, approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start5 Sep 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI LesionsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Spaete, Principal investigator, Duke Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011229
- Sponsor's protocol ID
- Pro00077315
- Status last verified
- May 2020
- First submitted
- 28 Dec 2016
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study
- ClinicalTrials.gov ID
- NCT03011229
- Acronym / sponsor ID
- Pro00077315
- Conditions
- GI Lesions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Jan 2017 (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 diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.
The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro Core | Active comparator | Device: Pro Core NeedleSubject is randomized to ProCore standard needle. |
| Medtronic Shark Core | Experimental | Device: medtronic Sharkcore NeedleSubject is randomized to Medtronic Sharkcore needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
- Women that have a negative pregnant test
Key exclusion criteria (7 listed)
- Patients under the age of 18.
- Uncorrectable coagulopathy (INR>1.5)
- Uncorrectable thrombocytopenia (platelet count <50,000)
- Patient who is unable to comply with study requirements
- Pregnant women
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 |
|---|---|---|
| Pro Core NeedleNeedle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles. | Device | Pro Core |
| medtronic Sharkcore NeedleNeedle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles. | Device | Medtronic Shark Core |
Primary outcome
diagnostic accuracy of biopsy needle
Time frame: end of biopsy, approximately 10 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
Related trials for GI Lesions
Not yet recruiting
Su2ura ESD Closure Pilot Study
ESD Defect, Gastric Epithelial Lesion
Recruiting
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection (ESD)
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.
Joshua Spaete principal investigator
Duke Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro Core Needle and medtronic Sharkcore Needle in people with GI Lesions, run by Duke 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 2 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: withdrawn, as of the sponsor's last update on 7 May 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 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 was withdrawn before enrolling participants, so there are no results.
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 of biopsy needle (time frame: end of biopsy, approximately 10 minutes). 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 7 May 2020.