Trials / Unknown
UnknownNCT03621852
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Philipps University Marburg · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..
Detailed description
The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation. The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoultrasound guided FNB | EUS FNB with Aquire TM device |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2019-07-01
- Completion
- 2020-07-01
- First posted
- 2018-08-09
- Last updated
- 2018-08-09
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03621852. Inclusion in this directory is not an endorsement.