EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Last updated: March 25, 2024
Sponsor: Orlando Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Colon Cancer

Stomach Cancer

Treatment

Endoscopic ultrasound examination

Clinical Study ID

NCT06340620
24.017.01
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Age < 18 years.
  • Unable to obtain consent for the procedure from either the patient or LAR.
  • Intrauterine pregnancy.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Endoscopic ultrasound examination
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Orlando Health

    Orlando, Florida 32806
    United States

    Active - Recruiting

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