Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Innovative Medicines Initiative
Ospedale San Raffaele
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Ulcerativ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For Phase A:
- male and female patients ≥ 18 years of age (at the time of signing the Informed Consent) -signed written Informed Consent
- established diagnosis of UC with a minimum disease duration of 3 months
- moderate, moderate to severe active UC, defined by partial Mayo Score
- indication to start any targeted therapy, yet not initiated
- in case of treatment with corticosteroid: stabile dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
- indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
- able to comply with the study procedures
- BMI \<23.
- For Phase B:
- male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
- signed written Informed Consent
- established diagnosis of UC and in clinical remission defined by partial Mayo Score with any targeted therapy
- able to comply with the study procedures
- BMI \<23.
- Exclusion Criteria for both phases:
- diagnosis of indeterminate colitis, Crohn's colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- absolute contraindications to colonoscopy procedures, complication during previous endoscopy
- bleeding disorders
- indication for surgery for UC
- legal incapacity
- rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
- treatment with \> 20 mg prednisone within 3 weeks prior to baseline
- anemia (hemoglobin \< 10 g/dl) at baseline
- pregnant or breastfeeding women
- women with implanted contraceptive device
- BMI\>23
- patients diagnosed with cancer (especially attention goes to colon-rectal neoplasty)
- high turnover osteoporosis
- presence of metal fragments
- joint prostheses
- varicous veins
- phlebitis and thrombophlebitis
- presence of pacemaker
- obliterating arteriopathy
- menstruation
- neoplastic tissues and surrounding areas
- tuberculosis
- individuals in the growing phase (children and adolescents)
- individuals not capable of communicating sense of pain
- any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason.
Exclusion
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06569888
Start Date
November 1 2024
End Date
June 30 2026
Last Update
August 26 2024
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