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Utility of Low Intensity Pulsed Ultrasound Stimulation (LIPUS) to Modulate the Release of Mediators Capable of Reflecting the Inflammatory State in the Affected Colonic Tract of Ulcerative Colitis Patients

NCT06569888 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-08-26

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether Low Intensity Pulsed Ultrasound (LIPUS) is capable of promoting the release of extracellular vesicles from the gut into the bloodstream of Ulcerative Colitis (UC) patients, whose content may be predictive of the inflammatory state of the mucosal source to aid the monitoring of the disease status and therapy response.

The main questions it aims to answer are:

Is LIPUS effective in inducing the release of biomarker-containing micro-vesicles into the bloodstream, capable of reflecting the inflammatory state of the mucosa during active disease?

Are there any extracellular vesicle-contained biomarkers that can monitor therapy during clinical remission?

Participants who undergo endoscopy and gut biopsy collection as per Standard Of Care, will:

* undergo abdominal ultrasound to establish the distance with the target tissue and consequently set the LIPUS device to supply the optimum energy established in the protocol.
* before LIPUS stimulation and 2 hours after stimulation, patients will have blood drawn
* an extra intestinal biopsy during endoscopy will be collected
* patients will be contacted 72h after intervention for adverse events monitoring

Conditions

Interventions

DEVICE

LIPUS stimulation

Low Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage

Sponsors & Collaborators

  • Innovative Medicines Initiative

    collaborator OTHER

  • Ospedale San Raffaele

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Alessandro Armuzzi, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-10-30
Completion
2026-06-30

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Diseases

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 NCT06569888 on ClinicalTrials.gov