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A Randomized Prospective Comparison of the New EUS Guided Acquire TM Needle Biopsy vs EUS Guided Fine Needle Aspiration for Suspected Solid Gastrointestinal Lesions

NCT03109639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-03-19

No results posted yet for this study

Summary

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable performance of molecular profiling and personalized oncologic therapy. The current needle used for tissue acquisition rarely provides tissue blocks needed for histology assessment. Hence, a better needle device with a good safety profile is needed to solve this technical difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty because of its unique designs. The additional cutting edge surface allows better tissue access and provides core tissue (\>90%) for histology. The safety profile of this new device is comparable to the conventional FNA needle thereby making it an ideal device for tissue acquisition.

Conditions

Interventions

DEVICE

Conventional EUS FNA needle

Participants randomised to Group A will undergo tissues acquisition using the Conventional EUS FNA needle and then crossed over to receive the experimental Acquire EUS- FNB device.

DEVICE

Acquire FNB device

Participants randomised to Group B will undergo tissue acquisition using the experimental Acquire EUS FNB device and then crossed over to receive the conventional EUS FNA needle

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2017-11-30
Completion
2017-11-30
FDA Device
Yes

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109639 on ClinicalTrials.gov