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Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle

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Thomas Jefferson University

Status

Terminated

Conditions

Cholangiocarcinoma
Lymphadenopathy
Pancreatic Cancer

Treatments

Device: 22G SharkCore™ needle
Device: 22G BNX EUS-FNA Needle

Study type

Interventional

Funder types

Other

Identifiers

NCT02872831
15G.533

Details and patient eligibility

About

The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue.

Full description

Rationale:

A tissue core biopsy with preserved architecture is critical to diagnose and fully characterize certain neoplasms, such as lymphomas and GI stromal tumors (GIST). Moreover, tissue specimens for histologic examination also provides the opportunity to immunostain the tissue, further increasing differential diagnostic capabilities; reach a specific diagnosis for benign diseases not always obtainable with a cytological sample, thus sparing patients from more invasive and risky sampling procedures or costly and unnecessary follow-up examinations; perform tissue profiling and/or cell culture needed to guide targeted therapies for individualized treatment of patients with cancer of the GI tract.

There has previously been no needle available on the market that can accurately and consistently acquire EUS-guided histologic tissue from solid gastrointestinal lesions. Covidien has recently released a novel SharkCore™ Fine Needle Biopsy (FNB) system for EUS-guided tissue acquisition of solid gastrointestinal lesions. With its unique bevel design, this needle has shown promising results to acquire histologic tissue as per oral communication with physicians around the country (Douglas Adler and Christopher DiMaio).

Currently, there is no published clinical data on the capability of the SharkCore™ needle to obtain specimens via EUS guidance. The rationale of the currently proposed trial is to assess the operating characteristics SharkCore™ needle system and to determine the ability of this needle system to yield histologic tissue.

Medtronic Inc. has provided us with an unrestricted grant in order to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX EUS-FNA.

Primary Objectives The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue.

Study Design We propose a prospective comparative study (22G SharkCore™ needle versus the 22G BNX EUS-FNA needle) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of solid pancreatic and gastrointestinal tumors. Up to 6 sites in the United States will enroll the patients. The respective institutional investigators will review serious adverse events throughout the study. No interim analysis is planned.

Enrollment

376 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Eligible patients will include anyone >18 years old that presents to the participating clinical institutions and requires an endosonographic evaluation for the presence of a solid-appearing mass lesion amenable to EUS access, and no contraindication to FNA as determined by standard clinical care

Exclusion criteria

  1. Refusal to participate in the study
  2. Solid-appearing mass lesion that in not amenable to EUS guided needle access for tissue acquisition
  3. Patients with incomplete medical records
  4. Pregnant patients
  5. Prisoners
  6. INR > 1.5
  7. Platelets < 50,000

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

376 participants in 2 patient groups

22G SharkCore™ needle
Active Comparator group
Description:
Covidien has recently released a novel SharkCore™ Fine Needle Biopsy (FNB) system for EUS-guided tissue acquisition of solid gastrointestinal lesions. With its unique bevel design, this needle has shown promising results to acquire histologic tissue as per oral communication with physicians around the country
Treatment:
Device: 22G SharkCore™ needle
22G BNX EUS-FNA needle
Active Comparator group
Description:
The standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle is routinely used for the evaluation of solid mass lesions in the pancreas and gastrointestinal tract.
Treatment:
Device: 22G BNX EUS-FNA Needle

Trial contacts and locations

1

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Central trial contact

Cynthia Miller, RN; Ali Siddiqui, MD

Data sourced from clinicaltrials.gov

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