Abdominal NeoplasmsNIFLEXNCT02307253
EUS GUIDED Transduodenal Biopsy Using the 19G Flex
A study testing Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) in people with Abdominal Neoplasms, run by Catholic University of the Sacred Heart at 6 sites in 4 countries.
Trial summary
This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Abdominal Neoplasms
- What is being tested?
- Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2013to Oct 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Informed consent is obtained.
Who cannot join
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
- They are unable to understand and/or read the consent form.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy3 sites
AUSL Bologna Bellaria-Maggiore Hospital
Bologna, 40139
ISMETT UPMC Italy
Palermo, 90100
Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
Rome, 00168
United States1 site
Indiana Univerisity Health Medical Center
Indianapolis, Indiana, 46202
Japan1 site
Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
Kawasaki, Kanagawa, 213-8507
About this study
Official title: EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study
This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
Read the detailed description
A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure.
The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies
The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.
- Conditions
- Abdominal Neoplasms
- Being tested
- Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
- Keywords
- EUS-guided biopsy, EUS-FNB
- Medical subject headings
- Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)Device
EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
| Study group | Role | What they receive |
|---|---|---|
| patients with solid lesions | Experimental | Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Receives: Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion
Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.
Measured: Intraoperative
Secondary outcomes (3)
Number of Complications Divided Per Total Number of Enrolled Patients
rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period
Measured: intraoperative and within 3 days after the procedure
Number of Histological Samples Judged Adequate Divided by the Total Number of Patients
percentage of patients in whom a histologically interpretable specimen will be retrieved
Measured: 5 days
Number of Correct Diagnosis Divided by the Total Number of Patients
rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy
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 posted4 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionOct 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Guido Costamagna, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307253
- Sponsor's protocol ID
- 7427/13
- Acronym
- NIFLEX
- Status last verified
- May 2022
- First submitted
- 19 Nov 2014
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455.
PubMed 22817786
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT02307253
- Acronym / sponsor ID
- NIFLEX / 7427/13
- Conditions
- Abdominal Neoplasms
- Keywords
- EUS-guided biopsy, EUS-FNB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 27 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
Detailed description
A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure.
The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies
The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with solid lesions | Experimental | Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Informed consent is obtained.
Key exclusion criteria (3 listed)
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
- They are unable to understand and/or read the consent form.
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 |
|---|---|---|
| Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle | Device | patients with solid lesions |
Primary outcome
Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion
Time frame: Intraoperative
Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.
3 secondary outcomes
Number of Complications Divided Per Total Number of Enrolled Patients
Time frame: intraoperative and within 3 days after the procedure
Number of Histological Samples Judged Adequate Divided by the Total Number of Patients
Time frame: 5 days
Number of Correct Diagnosis Divided by the Total Number of Patients
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22817786Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455.
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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.
Guido Costamagna, MD principal investigator
Catholic University of the Sacred Heart
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) in people with Abdominal Neoplasms, run by Catholic University of the Sacred Heart at 6 sites in 4 countries.
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 3 inclusion and 3 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States, France, Japan. 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 27 Jun 2022). 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?
Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307253, which also lists 1 linked publication.
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 27 Jun 2022.