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

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Brief Title

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

Official Title

Prospective Randomized Study of Utilizing the 22-gauge Standard FNA Needle Compared to the SharkCore™ 22-gauge Fine Needle Biopsy (FNB) Needle in Patients With Solid Mass Lesions of the Gastrointestinal Tract

Brief Summary

      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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Diagnostic Accuracy of the 22G SharkCore™ and the 22G BNX EUS-FNA needle

Secondary Outcome

 Sensitivity of the EUS Needles

Condition

Pancreatic Cancer

Intervention

22G SharkCore™ needle

Study Arms / Comparison Groups

 22G SharkCore™ needle
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

376

Start Date

July 2016

Completion Date

November 2017

Primary Completion Date

July 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ali Siddiqui, MD, 2159558900, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02872831

Organization ID

15G.533


Responsible Party

Sponsor

Study Sponsor

Thomas Jefferson University


Study Sponsor

Ali Siddiqui, MD, Principal Investigator, Thomas Jefferson University


Verification Date

October 2016