Recruiting

EndoSound Vision vs. Echoendoscope

Sponsor:

Orlando Health, Inc.

Code:

NCT06340620

Conditions

Pancreatic Disease

Pancreatic Cancer

Pancreatic Cyst

Gastrointestinal Tumor

Bile Duct Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic ultrasound examination

Study Details

Brief 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.

Conditions

Pancreatic Disease

Pancreatic Cancer

Pancreatic Cyst

Gastrointestinal Tumor

Bile Duct Diseases

Study ID

NCT06340620

Start date

Mar 25, 2024

Status verified date

Mar, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Standard echoendoscope

Standard echoendoscope will be used and EUS examination will be performed per standard of care.

active comparator: EndoSound Vision System

EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Interventions

Endoscopic ultrasound examination

Endoscopic ultrasound examination will be performed.

Primary outcome measure

  • Rate of successful completion of the requisite EUS examination [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Ji Young Bang, MD MPH

321-841-2431jiyoung.bang@orlandohealth.com

Barbara Broome

321-841-4356barbara.broome@orlandohealth.com

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Ji Young Bang, MD MPH

321-841-2431jiyoung.bang@orlandohealth.com

Barbara Broome

321-841-4356barbara.broome@orlandohealth.com

More Information

Sponsor

Orlando Health, Inc.

Last update posted

Apr 1, 2024

Last verified

Mar, 2024

Keywords

  • Endoscopic ultrasound
  • EndoSound Vision System
  • Randomized trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2024-04-01.