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Search / Trial NCT05474794

Detective Flow Imaging Endoscopic Ultrasonography in Subepithelial Lesions

Launched by INSTITUTO ECUATORIANO DE ENFERMEDADES DIGESTIVAS · Jul 23, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Subepithelial Lesion Detective Flow Imaging Endoscopic Ultrasound Guided Fine Needle Aspiration

ClinConnect Summary

This clinical trial is studying a new method called detective flow imaging endoscopic ultrasonography (DFI-EUS) to help doctors better diagnose certain growths in the digestive system known as subepithelial lesions (SELs). These lesions can be benign, like leiomyomas, or malignant, like gastrointestinal stromal tumors (GISTs). The goal is to see if DFI-EUS can effectively identify these lesions without using contrast agents, which can sometimes cause side effects in patients. By comparing DFI-EUS with another technique called contrast-enhanced endoscopic ultrasound (CE-EUS), researchers hope to find a safer and more accurate way to diagnose these conditions.

To participate in the trial, patients need to be between the ages of 18 and 80 and should have been referred for an ultrasound to evaluate SELs. They must also be able to provide written consent to take part in the study. Those who have certain health issues that prevent the use of contrast agents or are pregnant cannot join. Participants will undergo the DFI-EUS or CE-EUS procedures, and they can expect to receive thorough monitoring and care throughout the trial. This research is important as it may lead to better diagnosis and treatment options for patients with these types of lesions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients referred to our center with an indication of EUS for the evaluation of SELs
  • Patients who authorized for DFI or CE-EUS.
  • Written informed consent
  • Exclusion Criteria:
  • Patients with contraindication for contrast agent administration.
  • Any clinical condition which makes EUS-DFI or CE-EUS inviable
  • Pregnancy

About Instituto Ecuatoriano De Enfermedades Digestivas

The Instituto Ecuatoriano de Enfermedades Digestivas (IEED) is a leading clinical research organization dedicated to advancing gastrointestinal health through innovative research and clinical trials. Committed to improving patient outcomes, IEED focuses on the prevention, diagnosis, and treatment of digestive diseases, leveraging state-of-the-art technology and a multidisciplinary team of experts. With a strong emphasis on ethical practices and patient safety, the institute collaborates with national and international partners to contribute to the global understanding of digestive disorders and enhance therapeutic options for patients.

Locations

Guayaquil, Guayas, Ecuador

Patients applied

0 patients applied

Trial Officials

Carlos Robles-Medranda, MD FASGE

Principal Investigator

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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