At a glance
ClinicalIndex Comparison RecordN/ACompleted· 246 enrolled
Drug / intervention
Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study
In Brief
A clinical study evaluating Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) for Abdominal Neoplasms. Completed, enrolled 246 participants across 6 sites in 4 countries.
Detailed 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. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Neoplasms
CountriesFrance, Italy, Japan, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedDec 2014
Primary CompletionOct 2015
TodayJul 2026
First PostedDec 4, 2014
Enrollment StartJun 1, 2013
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.6 years ago
Interventions
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