Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001247763
Ethics application status
Approved
Date submitted
24/06/2022
Date registered
15/09/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
15/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Ultrasound with Mesalazine Enema
Scientific title
Open label trial to assess safety and tolerability of ultrasound mediated mesalazine rectal suspension enema in healthy participants
Secondary ID [1] 307332 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis 326617 0
Condition category
Condition code
Oral and Gastrointestinal 323870 323870 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323771 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331680 0
To determine safety and tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by gross examinations of tissue during colonoscopy and histological examinations (Hematoxylin & Eosin [H&E] stain) of biopsied colon tissue.
Timepoint [1] 331680 0
Day of procedure
Primary outcome [2] 331683 0
To determine safety and tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by analysis of blood for complete blood count with differential, comprehensive metabolic panel, and systemic drug levels pre- and post-treatment.
Timepoint [2] 331683 0
Baseline and day of procedure
Primary outcome [3] 331684 0
To determine tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by participant and clinician feedback. Feedback will be collected using a study specific questionnaire containing open ended questions and 10 point likert scales.
Timepoint [3] 331684 0
Day of procedure
Secondary outcome [1] 410783 0
To determine the concentration of mesalazine in colon tissue biopsies.
Timepoint [1] 410783 0
Day of procedure
Secondary outcome [2] 410784 0
Capture treatment-emergent adverse events (TEAEs) during and immediately after the procedure and a follow up call. All adverse events will be recorded on case report forms. Potential adverse events could include anal discomfort or pain, mucosal erythema, abrasion, or bleeding.
Timepoint [2] 410784 0
Day of procedure and 3-7 days post treatment follow up call

Eligibility
Key inclusion criteria
* Undergoing routine colonoscopy procedure
* Signed informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
No statistical methods used; first in human study for exploratory investigations to determine preliminary safety and performance information to plan for design modifications and provide support for a future pivotal studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/12/2022
Actual
20/12/2022
Date of last participant enrolment
Anticipated
Actual
23/05/2023
Date of last data collection
Anticipated
Actual
29/05/2023
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22618 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 37883 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311624 0
Commercial sector/Industry
Name [1] 311624 0
Suono Bio
Country [1] 311624 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Suono Bio
Address
200 Foxborough Blvd
Suite 100
Foxboro, Massachusetts 02035
Country
United States of America
Secondary sponsor category [1] 313060 0
Commercial sector/Industry
Name [1] 313060 0
Avania Australia
Address [1] 313060 0
13/76 Reserve Road
Artarmon NSW 2064
Country [1] 313060 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311080 0
Bellberry Limited
Ethics committee address [1] 311080 0
Bellberry Location 123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 311080 0
Australia
Date submitted for ethics approval [1] 311080 0
14/09/2022
Approval date [1] 311080 0
25/10/2022
Ethics approval number [1] 311080 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119870 0
A/Prof Jakob Begun, MD, PhD
Address 119870 0
Mater Hospital Brisbane
Raymond Terrace
South Brisbane QLD 4101
Country 119870 0
Australia
Phone 119870 0
+61 7 31632798
Fax 119870 0
Email 119870 0
[email protected]
Contact person for public queries
Name 119871 0
Morgan Brophy
Address 119871 0
Suono Bio
200 Foxborough Blvd, Suite 100
Foxboro, Massachusetts 02035
Country 119871 0
United States of America
Phone 119871 0
+1 843 991 9691
Fax 119871 0
Email 119871 0
[email protected]
Contact person for scientific queries
Name 119872 0
Morgan Brophy
Address 119872 0
Suono Bio
200 Foxborough Blvd, Suite 100
Foxboro, Massachusetts 02035
Country 119872 0
United States of America
Phone 119872 0
+1 843 991 9691
Fax 119872 0
Email 119872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.