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NCT Number: NCT06340620

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

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.

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Key information

Conditions

Pancreatic Disease Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cysts Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Tumor Lymph Node Disease Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Cyst Pancreatic Diseases Pancreatic Neoplasms Submucosal Tumor of Gastrointestinal Tract

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic ultrasound examination

Device

Endoscopic ultrasound examination will be performed.

Primary outcomes

  1. Rate of successful completion of the requisite EUS examination

    Time frame: 1 day

    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.

Secondary outcomes

  1. Ease of maneuverability of the device

    Time frame: 1 day

    The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver).

  2. Quality of EUS imaging

    Time frame: 1 day

    The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging).

  3. Ease of performing tissue acquisition

    Time frame: 1 day

    The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform).

  4. Diagnostic adequacy of procured specimen on onsite evaluation

    Time frame: 7 days

    Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes.

  5. Diagnostic adequacy of procured specimen in cell block

    Time frame: 7 days

    Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes.

  6. Diagnostic accuracy of procured specimen

    Time frame: 7 days

    Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.

  7. Procedure duration

    Time frame: 1 day

    Duration of procedure between the EndoSound Vision System and standard echoendoscopes.

  8. Rate of procedure-related adverse events

    Time frame: 7 days

    Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.

  9. Procedure costs

    Time frame: 7 days

    Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Broome

CONTACT

[email protected]

321-841-4356

Ji Young Bang, MD MPH

CONTACT

[email protected]

321-841-2431

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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