Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000868482
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
11/08/2025
Date last updated
11/08/2025
Date data sharing statement initially provided
11/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Investigation on the Safety and Feasibility of the investigative endoscopic system in the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions.
Scientific title
Robotic-AssistEd Trans-Oral GastrointestiNal (GI) Assessment ProspecTive Evaluation: The RESONATE Study
Secondary ID [1] 314727 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RESONATE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper GI Bleeding 337929 0
Upper GI Biopsy 338141 0
Gastric Intestinal Metaplasia or Dysplasia 338142 0
Gastric Ulcers 338145 0
Condition category
Condition code
Oral and Gastrointestinal 334252 334252 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research study is to assess the safety and feasibility of a new device designed for the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions. Subjects will undergo a procedure with a device which is a software- controlled, electro-mechanical system designed to assist qualified physicians to navigate a GI endoscope and endoscopic tools in the upper GI tract using endoscopic visualization for observation, diagnostic procedures, and/or endoscopic treatment. The device is similar to a conventional endoscopy; the investigational device will be inserted through the mouth and navigated into the upper GI tract. Procedures will occur in an endoscopy theatre and will be performed by qualified physicians. Procedures may be performed under general anesthesia or moderate sedation. Patients will be informed of the anesthesia method prior to the procedure. The study procedure will last for approximately 60 minutes. Patients will be monitored in the hospital post-procedure and prior to discharge and will complete one follow-up visit via clinic visit or telehealth within 30 days of the procedure. Follow up is in accordance with the follow-up practice for this procedure without an investigational device and will involve the study doctor asking the patient whether they experienced any adverse events including any hospitalizations. Patients can also self-monitor themselves and in the event of a suspected complication, they can contact the study team.

Strategies used to assess adherence to the intervention include photo documentation of the access to landmarks in the upper GI tract in the same manner as standard EGD or other endoscopy procedures.
Intervention code [1] 331330 0
Treatment: Devices
Intervention code [2] 331467 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341916 0
Feasibility
Timepoint [1] 341916 0
Post-procedure
Primary outcome [2] 341917 0
Safety
Timepoint [2] 341917 0
Daily up to the 30-day follow-up period.
Secondary outcome [1] 449013 0
Nil
Timepoint [1] 449013 0
Nil

Eligibility
Key inclusion criteria
1. Subject is greater than or equal to 22 years old and less than 80 years old at the time consent.
2. Subject is suitable for and is planned to undergo an elective outpatient EGD procedure according to local guidelines
Minimum age
22 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects for whom routine EGD procedures are contraindicated due to comorbid medical conditions per GESA/ASGE guidelines
2. Subjects with American Society of Anesthesiologists (ASA) classification greater than or equal to 4.
3. Subjects with clinically significant acute GI pathology such as acute GI bleeding (variceal and non-variceal), inability to swallow liquids or solids or other pathology as assessed by the Investigator
4. Women of child-bearing potential must not be pregnant as confirmed with a negative urine or serum beta human chorionic gonadotropin test no more than 24 hours prior to the index procedure

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
A sample size of 30 evaluable subjects is chosen to provide reasonable precision for the primary performance endpoint. As the study has no hypotheses, statistical power is not a consideration.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/07/2025
Date of last participant enrolment
Anticipated
Actual
21/07/2025
Date of last data collection
Anticipated
28/08/2025
Actual
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28144 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 44350 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 319279 0
Commercial sector/Industry
Name [1] 319279 0
Ascend Clinical Research Organisation, Pty Ltd.
Country [1] 319279 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascend Clinical Research Organisation, Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 321752 0
None
Name [1] 321752 0
Address [1] 321752 0
Country [1] 321752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317856 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 317856 0
Ethics committee country [1] 317856 0
Australia
Date submitted for ethics approval [1] 317856 0
15/04/2025
Approval date [1] 317856 0
15/05/2025
Ethics approval number [1] 317856 0

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

Contacts
Principal investigator
Name 142370 0
Dr Michael Talbot
Address 142370 0
St George Private Hospital, Suite 3, Level 5, 1 South St, Kogarah NSW 2217 Australia
Country 142370 0
Australia
Phone 142370 0
+61 2 9553 1120
Fax 142370 0
Email 142370 0
[email protected]
Contact person for public queries
Name 142371 0
Dr Michael Talbot
Address 142371 0
St George Private Hospital, Suite 3, Level 5, 1 South St, Kogarah NSW 2217 Australia
Country 142371 0
Australia
Phone 142371 0
+61 2 9553 1120
Fax 142371 0
Email 142371 0
[email protected]
Contact person for scientific queries
Name 142372 0
Dr Michael Talbot
Address 142372 0
St George Private Hospital, Suite 3, Level 5, 1 South St, Kogarah NSW 2217 Australia
Country 142372 0
Australia
Phone 142372 0
+61 2 9553 1120
Fax 142372 0
Email 142372 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.