None listed
Conditions
Brief summary
This study evaluates the safety and tolerability of the Suono 1 System, a low frequency ultrasound device intended to enhance mesalazine drug concentrations in colon tissue without increasing systemic (bloodstream) concentrations. Mesalazine is an approved therapeutic used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers on the inner lining of the large intestine. Patients with a UC flare are prescribed mesalazine enemas for daily use until condition improves. This preliminary study will assess safety and tolerability of ultrasound mediated mesalazine enemas in healthy participants. It is expected that ultrasound mediated mesalazine enemas will be tolerable and exhibit gross and cellular tissue appearance with no clinical significance.
Interventions
Subjects will be healthy participants scheduled for routine colonoscopy. Baseline blood work will be collected within 30 days of the procedure. On the day of the scheduled colonoscopy the principal investigator will insert the Suono Calm device (low-frequency ultrasound probe) and instill a mesalazine enema (4g/60mL suspension) through the device port. A 2 minute ultrasound treatment will be activated. The device is removed and the enema is to be evacuated. A fleet enema will be administered imm
Subjects will be healthy participants scheduled for routine colonoscopy. Baseline blood work will be collected within 30 days of the procedure. On the day of the scheduled colonoscopy the principal investigator will insert the Suono Calm device (low-frequency ultrasound probe) and instill a mesalazine enema (4g/60mL suspension) through the device port. A 2 minute ultrasound treatment will be activated. The device is removed and the enema is to be evacuated. A fleet enema will be administered immediately after to rinse out residual mesalazine. The process, including mesalazine enema, ultrasound treatment, and fleet enema, is expected to take no more than 5-10 minutes. Participant will be requested to complete a 5 minute questionnaire rating the experience. Participant will proceed with the colonoscopy for visual observation and collection of 4 colon tissue biopsies. Biopsies will be used for histological analysis and drug concentration for study endpoints. One hour after mesalazine enema, final blood work will be collected. The entire procedure will be conducted at a clinic by the trained principal investigator following an approved protocol and case report forms including procedure checklist. A brief follow-up call will be conducted 3-7 days after the procedure.
Sponsors
Suono Bio
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergoing routine colonoscopy procedure * Signed informed consent
Exclusion criteria
* Current known presentation of hemorrhoids or rectal bleeding * Pregnant or breast feeding * History of salicylate allergy * Previous bowel resection * Clinically significant hepatic or renal disease * Participating in a clinical trial within 1 month * History or signs of IBD (Crohn’s disease, UC) or cancer * Insufficient / no preparation for colonoscopy * Currently taking 5-ASA based oral medication * Currently taking anti-coagulants or anti-platelet agents * Currently taking glucocorticoids, sulphonylureas, methotrexate, probenecid/sulphinpyrazone, spironolactone/frusemide, rifampicin, azathioprine, mercaptopurine or thioguanine
Outcome results
None listed