Solid Mass Lesions in GI TractNCT03561038
Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.
A study testing Franseen Needle and Fork-tip Needle in people with Solid Mass Lesions in GI Tract, run by University of Arkansas.
Trial summary
This will be a randomized controlled trial of all the patients referred to University of Arkansas Medical for Medical Sciences (UAMS) for endoscopic ultrasound (EUS) guided biopsy of solid mass lesions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Solid Mass Lesions in GI Tract
- What is being tested?
- Franseen Needle and Fork-tip Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects from any ethnic background
- Successfully completes the screening process
- Has signed written informed consent by patient or surrogate
- Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of study questionnaires.
- Patients must have evidence of a lesion seen on endoscopic ultrasound that is accessible
- Lack of severe or terminal co-morbidity, as judged by the generalists or specialists caring for the patient.
Who cannot join
- History of allergic reaction of hypersensitivity to the medications / anesthesia.
- Female participants of childbearing age who are pregnant
- Female participants who are breastfeeding.
- Participant has history of significant cardiovascular or pulmonary disease (e.g., myocardial infarct, unstable angina, congestive heart failure, arrhythmia, pulmonary edema or COPD), or other significant cerebrovascular disease (stroke)
- Patients who are uncooperative, unable to give written informed consent, who cannot return for follow-up, or refuse informed consent
- Persistent shock or hypertension (e.g., systolic blood pressure less than or equal to 99 mm mercury) that is unresponsive to less than or equal to 6 units of packed red blood cell (RBC) transfusions or requires continuous intravenous infusions of vasoactive drugs for blood pressure elevation.
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- Severe coagulopathy unresponsive to blood transfusions (e.g., international normalized ratio >2.0, platelet count <20,000. activated partial thromboplastin time greater than 2.0 x normal, or bleeding time > 10 minutes)
- Contraindication to urgent endoscopy or follow-up procedures or inaccessible due to altered anatomy, moderate / tense ascites.
- Participant has uncontrolled diabetes / uncontrolled hypertension / severe immunodeficiency.
About this study
Official title: Randomized Trial Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.
This will be a randomized controlled trial of all the patients referred to University of Arkansas Medical for Medical Sciences (UAMS) for endoscopic ultrasound (EUS) guided biopsy of solid mass lesions. EUS guided tissue acquisition will be performed in all these patients using both needle types (22-gauge Franseen Fine Needle Biopsy (FNB) (Acquire, Boston Scientific Corporation, Natick, Mass) and 22-gauge Fork-tip FNB needle (SharkCore, Medtronic)) with randomization of the order in which the needle will be used.
Read the detailed description
All procedures will be performed by the advance endoscopists Dr Sumant Inamdar (SI) and Dr Benjamin Tharian (BT) using a linear array echoendoscope (Olympus UCT180, Olympus America Corp, Center Valley, Pa) with patients in the left lateral decubitus position after administration of anesthesia (propofol or general anesthesia). During EUS, the mass will first be punctured using either needle based on the randomization assignment. Tissue acquisition will be performed using the fanning maneuver (4 strokes at 4 different locations within the mass). After performing 2 dedicated passes for cell block for histological analysis using the randomized needle, 2 additional passes will be made for cell block with the alternate needle. Sample obtained from each pass is placed into a separate container to be analysed separately. The occurrence of immediate adverse events will be noted at the time of procedure, and late adverse events will be documented by follow-up telephone calls at 1 week post-procedure
- Conditions
- Solid Mass Lesions in GI Tract
- Being tested
- Franseen Needle, Fork-tip Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Franseen NeedleDevice
Comparing 2 needles designed for tissue acquisition
Fork-tip NeedleDevice
Comparing 2 needles designed for tissue acquisition
| Study group | Role | What they receive |
|---|---|---|
| Franseen Needle | Active comparator | 2 strokes within the mass with Franseen Needle, and then 2 strokes with the Fork-tip Needle Receives: Device: Franseen Needle |
| Fork-tip Needle | Active comparator | 2 strokes within the mass with Fork-Tip needle, and then 2 strokes with the Franseen Needle Receives: Device: Fork-tip Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
comparing rates of diagnostic yield between the 2 cohorts.
Measured: Up to 2 years
Secondary outcomes (1)
Histology
Histology will be evaluated
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Apr 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: Similar study just got done
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Mass Lesions in GI TractStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumant Inamdar, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561038
- Sponsor's protocol ID
- 217910
- Status last verified
- Apr 2019
- First submitted
- 6 Jun 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.
- ClinicalTrials.gov ID
- NCT03561038
- Acronym / sponsor ID
- 217910
- Conditions
- Solid Mass Lesions in GI Tract
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar study just got done
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- 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.
This will be a randomized controlled trial of all the patients referred to University of Arkansas Medical for Medical Sciences (UAMS) for endoscopic ultrasound (EUS) guided biopsy of solid mass lesions. EUS guided tissue acquisition will be performed in all these patients using both needle types (22-gauge Franseen Fine Needle Biopsy (FNB) (Acquire, Boston Scientific Corporation, Natick, Mass) and 22-gauge Fork-tip FNB needle (SharkCore, Medtronic)) with randomization of the order in which the needle will be used.
Detailed description
All procedures will be performed by the advance endoscopists Dr Sumant Inamdar (SI) and Dr Benjamin Tharian (BT) using a linear array echoendoscope (Olympus UCT180, Olympus America Corp, Center Valley, Pa) with patients in the left lateral decubitus position after administration of anesthesia (propofol or general anesthesia). During EUS, the mass will first be punctured using either needle based on the randomization assignment. Tissue acquisition will be performed using the fanning maneuver (4 strokes at 4 different locations within the mass). After performing 2 dedicated passes for cell block for histological analysis using the randomized needle, 2 additional passes will be made for cell block with the alternate needle. Sample obtained from each pass is placed into a separate container to be analysed separately. The occurrence of immediate adverse events will be noted at the time of procedure, and late adverse events will be documented by follow-up telephone calls at 1 week post-procedure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Franseen Needle | Active comparator | Device: Franseen Needle2 strokes within the mass with Franseen Needle, and then 2 strokes with the Fork-tip Needle |
| Fork-tip Needle | Active comparator | Device: Fork-tip Needle2 strokes within the mass with Fork-Tip needle, and then 2 strokes with the Franseen Needle |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects from any ethnic background
- Successfully completes the screening process
- Has signed written informed consent by patient or surrogate
- Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of study questionnaires.
- Patients must have evidence of a lesion seen on endoscopic ultrasound that is accessible
Key exclusion criteria (9 listed)
- History of allergic reaction of hypersensitivity to the medications / anesthesia.
- Female participants of childbearing age who are pregnant
- Female participants who are breastfeeding.
- Participant has history of significant cardiovascular or pulmonary disease (e.g., myocardial infarct, unstable angina, congestive heart failure, arrhythmia, pulmonary edema or COPD), or other significant cerebrovascular disease (stroke)
- Patients who are uncooperative, unable to give written informed consent, who cannot return for follow-up, or refuse informed consent
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 |
|---|---|---|
| Franseen NeedleComparing 2 needles designed for tissue acquisition | Device | Franseen Needle |
| Fork-tip NeedleComparing 2 needles designed for tissue acquisition | Device | Fork-tip Needle |
Primary outcome
Diagnostic Yield
Time frame: Up to 2 years
comparing rates of diagnostic yield between the 2 cohorts.
1 secondary outcome
Histology
Time frame: up to 2 years
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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.
Sumant Inamdar, MD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A study testing Franseen Needle and Fork-tip Needle in people with Solid Mass Lesions in GI Tract, run by University of Arkansas.
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 6 inclusion and 9 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 3 Sep 2024. 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 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 Yield (time frame: Up to 2 years). 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 3 Sep 2024; AzTrials last refreshed its copy on 4 Nov 2026.