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Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage

NCT00732212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2023-12-04

Study results available
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Summary

The main purposes of this study are to compare clinical outcomes of two groups of patients with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions such as ulcers and another group with varices or portal hypertensive lesions) who are treated either with current standard visually guided endoscopic treatment according to stigmata of hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood flow in the lesion.

Conditions

  • UGI Bleeding
  • Ulcer or Variceal Hemorrhage
  • Stigmata of Recent Hemorrhage
  • Endoscopy
  • Randomized Controlled Trials

Interventions

DEVICE

Doppler endoscopic ultrasound probe for blood flow detection

Used for blood flow detection

OTHER

Standard endoscopic hemostasis

Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage \& visual cues for risk stratification and completion of endoscopic treatment.

Sponsors & Collaborators

Principal Investigators

  • Dennis M. Jensen, MD · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-18
Primary Completion
2016-01-07
Completion
2016-01-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732212 on ClinicalTrials.gov