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SuonoBio - Evaluation of Ultrasound with Mesalazine Enema in Healthy Participants

Ulcerative colitis

Healthy participants who are undergoing a routine colonoscopy are invited to take part in this research project. The study is testing a potential new treatment for patients with ulcerative colitis, a chronic inflammatory bowel disease. The investigational product is called Suono 1 System and involves application of ultrasound to the rectum in combination with an approved enema containing the medication mesalazine.

The primary aim of study is to assess the safety and tolerability of treatment with the Suono 1 System.

The secondary aim is to measure availability of mesalazine in the colon following treatment with the investigational product.

Category
Trial Status
Active, not recruiting
Trial Phase
Phase 1 Drug Trial
Registry Listing
Trial contact details
Contact Person
IBD Clinical Trials Unit
Email
Phone
What you need to know

Who can take part?

  • Adults (18-70 years)
  • Undergoing routine colonoscopy

Exclusions

  • Current known haemorrhoids or rectal bleeding
  • Pregnant or breast feeding
  • History of allergy to aspirin
  • Previous bowel resection
  • Liver or kidney disease
  • Participating in another clinical trial within the past month
  • History or signs of Crohn’s disease, Ulcerative Colitis or cancer
  • People taking certain medications may be excluded from participation

What is involved for you? 

The duration of your participation is one day plus a follow up call within 3-7 days of the colonoscopy. Participants will undergo the following tests and procedures in addition to the colonoscopy which is being performed as standard medical care:

  • Medical history
  • Blood tests
  • Mesalazine enema with ultrasound treatment
  • Imaging and collection of colon tissue biopsy during the colonoscopy
  • Health questionannaires
  • Follow-up phone call with health questionnaires

Trial dates

December 2022 to April 2023

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