Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000780459
Ethics application status
Approved
Date submitted
30/03/2025
Date registered
24/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
24/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A safety and feasibility study of the delivery of energy pulses within the intestine.
Scientific title
A PRospectivE InveStigation of The Feasibility and Safety Of Duodenal Mucosal Regeneration for Type 2 Diabetes Mellitus Using Novel Endoscopic Ablation (“RESTORE Study”)
Secondary ID [1] 314084 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 336854 0
Condition category
Condition code
Metabolic and Endocrine 333330 333330 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single-arm, interventional study evaluating the safety of a new device designed for the delivery of a low energy pulse to part of the intestine from inside the body. The new device is a gastroscope designed for endoscopic procedures within the gastrointestinal (GI) tract. Structurally and functionally, it resembles conventional gastroscopes used for diagnostic and therapeutic interventions. The device will be inserted through the mouth and the physician will guide the catheter to the location in the duodenum where the treatment will be applied. Upon positioning, energy will be delivered through the study device to the target area specified by the physician.

The energy pulse will come from a generator and be delivered by a tool from inside the body that is similar in size to other commonly used tools. The energy provided is a non-thermal that will be delivered through the study device within the duodenum. Up to 9 locations in the duodenum may be treated under the investigator's discretion at a specific dosage. The duration of energy delivery is approximately 1 minute at each site. The procedure will last approximately 30 minutes. The treatment will be provided during the study procedure. There will be no additional treatments administered using the study device after the study procedure is completed.

The study procedure will be performed by a highly trained gastroenterologist in an endoscopy suite. The gastroenterologist will be trained on the use of the device prior to the start of procedures. No study specific training is needed for any follow-up assessments. Adherence to the intervention will be assessed through follow-up visits performed by the study team as well as a review of medical records.
Intervention code [1] 330659 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340904 0
Incidence of all serious intra-procedure and post-procedure adverse events (complications) related to the device. This will be a composite outcome (overall rate), however a rate for each time-point will be reported as well.
Timepoint [1] 340904 0
Daily up to 4 weeks post procedure. The rate will be reported at the following timepoints: overall rate through 30 days, post-procedure prior to discharge and from discharge to 30 days (rate of post-procedure prior to discharge + rate of discharge to 30 days = overall rate through 30 days)
Secondary outcome [1] 445395 0
Successful completion of procedure
Timepoint [1] 445395 0
Prior to discharge of the subject. This timepoint is prior to discharge from the hospital; the period from when the patient leaves the procedure room to when the patient leaves the hospital.
Secondary outcome [2] 445396 0
Achievement of disease control
Timepoint [2] 445396 0
At the 13-week follow-up visit.
Secondary outcome [3] 445397 0
Incidence of intra-procedure and post-procedure procedure-related adverse events,
Timepoint [3] 445397 0
Daily up to the 26-week follow-up period.

Eligibility
Key inclusion criteria
1. Current diagnosis of type 2 disease diagnosed within 10 years of the planned procedure
2. BMI is between 22 and 40 kg/m2
3. Able to comply with study requirements and understand and sign the Informed Consent Form
Minimum age
22 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- American Society of Anesthesia Classification of 4 or higher
- Previous gastrointestinal surgery that altered gastrointestinal anatomy including but not limited to Roux-en-Y gastric bypass, sleeve gastrectomy, small bowel surgery/anastomosis and/or altered stomach-duodenum anatomy.
- Contraindicated for general anesthetic agents.
- Women of child-bearing potential who is pregnant, breastfeeding, lactating, or will not agree to use contraception throughout the duration of study.
- Participating in another clinical investigation with an investigational drug or device within three (3) months of enrolment or planned participation at any time during this clinical investigation.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27675 0
Footscray Hospital - Footscray
Recruitment hospital [2] 27676 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 43850 0
3011 - Footscray
Recruitment postcode(s) [2] 43851 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 318592 0
Commercial sector/Industry
Name [1] 318592 0
Ascend Clinical Research Organisation, Pty Ltd.
Country [1] 318592 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascend Clinical Research Organisation, Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 320990 0
None
Name [1] 320990 0
Address [1] 320990 0
Country [1] 320990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317191 0
Bellberry Human Research Ethics Committee E
Ethics committee address [1] 317191 0
Ethics committee country [1] 317191 0
Australia
Date submitted for ethics approval [1] 317191 0
04/12/2024
Approval date [1] 317191 0
09/01/2025
Ethics approval number [1] 317191 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140298 0
Prof Alan Moss
Address 140298 0
Footscray Hospital, Western Health 160 Gordon St, Footscray VIC 3011, Australia
Country 140298 0
Australia
Phone 140298 0
+61 383456666
Fax 140298 0
Email 140298 0
[email protected]
Contact person for public queries
Name 140299 0
Clin. Prof. Alan Moss
Address 140299 0
Footscray Hospital, Western Health 160 Gordon St, Footscray VIC 3011, Australia
Country 140299 0
Australia
Phone 140299 0
+61 383456666
Fax 140299 0
Email 140299 0
[email protected]
Contact person for scientific queries
Name 140300 0
Clin. Prof. Alan Moss
Address 140300 0
Footscray Hospital, Western Health 160 Gordon St, Footscray VIC 3011, Australia
Country 140300 0
Australia
Phone 140300 0
+61 383456666
Fax 140300 0
Email 140300 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: IPD will not be available.



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.