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RecruitingInterventional

Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope

NCT ID: NCT06340620Sponsor: Orlando Health, Inc.Last updated: 2024-04-01

Summary

This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Detailed description

Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination. The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Arms & interventions

  • DeviceEndoscopic ultrasound examination

    Endoscopic ultrasound examination will be performed.

Outcome measures

Primary

  • Rate of successful completion of the requisite EUS examination

    Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.

    Time frame: 1 day

Secondary

  • Ease of maneuverability of the device

    Time frame: 1 day

  • Quality of EUS imaging

    Time frame: 1 day

  • Ease of performing tissue acquisition

    Time frame: 1 day

  • Diagnostic adequacy of procured specimen on onsite evaluation

    Time frame: 7 days

  • Diagnostic adequacy of procured specimen in cell block

    Time frame: 7 days

  • Diagnostic accuracy of procured specimen

    Time frame: 7 days

  • Procedure duration

    Time frame: 1 day

  • Rate of procedure-related adverse events

    Time frame: 7 days

  • Procedure costs

    Time frame: 7 days

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy volunteers: No
Inclusion Criteria: * Age ≥ 18 years * Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon. Exclusion Criteria: * Age \< 18 years. * Unable to obtain consent for the procedure from either the patient or LAR. * Intrauterine pregnancy.

Study locations (1)

Orlando Health

Orlando, Florida, 32806

Recruiting