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NCT06569888: LIPUSinVIVO
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
NA trial testing LIPUS stimulation in Ulcerative Colitis in 90 participants. Not yet recruiting.
30 October 2025
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 90 |
| Start date | 1 November 2024 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 June 2026 |
Drugs / interventions tested
- LIPUS stimulation
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Istituto Clinico Humanitas
Who can join
18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06569888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
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- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Istituto Clinico Humanitas trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06569888 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 26 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06569888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing