Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000427572
Ethics application status
Approved
Date submitted
31/01/2024
Date registered
8/04/2024
Date last updated
8/04/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing automated chyme reinfusion therapy with The Insides System
Scientific title
Enhancing automated chyme reinfusion therapy with The Insides System in adults with small bowel stomas and enteroatmospheric fistulas
Secondary ID [1] 311445 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ostomy 332734 0
Small bowel stoma 332956 0
enteroatmospheric fistula 332957 0
Condition category
Condition code
Diet and Nutrition 329452 329452 0 0
Other diet and nutrition disorders
Surgery 329453 329453 0 0
Other surgery
Oral and Gastrointestinal 329454 329454 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
What is the purpose of the study:
Surgery to treat bowel cancer or other bowel diseases can involve formation of a ‘temporary stoma’. Small bowel stomas mean that chyme (gut contents) exit the small intestine and flow into a ‘stoma bag’ on the abdomen, instead of passing into the colon. “Temporary stomas” are usually reversed when it is safe to operate.
The colon normally reabsorbs a lot of gut fluid. But when a patient has a stoma, this reabsorption cannot occur because it is being diverted out through the stoma, into a stoma bag before it can reach the colon. Some patients become dehydrated. Sometimes patients need to have medications or fluids to prevent dehydration. About 15% of patients have to be re-admitted to hospital for extra fluids.
A stoma can cause other difficulties. Some patients find managing a stoma bag bothersome. Stomas may leak or cause skin irritation. Having a stoma can have a negative impact on quality of life.
Chyme reinfusion therapy is when the chyme which comes out of the stoma is put back into the distal intestine. This fluid then travels through the rest of the intestine, and colon which absorbs the fluid and nutrients. The leftover waste forms a stool or bowel motion. Chyme reinfusion therapy has been used safely for many decades. It is approved by many of the leading authorities on nutrition for example European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN).
The Insides System is a commercially available medical device designed to perform chyme reinfusion therapy. It comprises three components: a tube, pump, and driver. The tube is inserted into the distal intestine (downstream end) of the stoma, and the pump attaches to the end of the tube. The tube and pump within the stoma bag, collecting chyme from the stoma. When the bag is filled with chyme, a driver couples to the pump from outside the stoma bag, causing chyme to move from the bag up into the tube, and into the downstream intestine. The Insides System, in its current form, has been used commercially in over 300 intestinal failure patients globally. Although this device has been used successfully around the world, feedback from patients and clinicians have requested improvements to the tube and driver are being considered to make it even easier to use.
This study involves testing an improved version of The Insides System in the hope that the investigational version of the device can be used to perform chyme reinfusion and improve care in a wider range of patients.

What is being studied:
-The Insides Tube (Self Insertable)
A straight ended tube has been developed which can be inserted by the participant or their carer. It is secured to the stoma bag and as the stoma bag is applied to the skin the tube is slowly inserted into the distal limb of the stoma.
-The Insides Driver
Two different versions of The Insides Driver have been developed which participants will be asked to trial:
Driver A: Remote monitoring
The remote monitoring is a new feature to the existing driver. The driver has remote monitoring built in to capture use of the driver such as length of time it is turned on, what speed is used, and the volume reinfused. This information will be stored against the driver serial number on a secure website online and remotely viewed by a clinician. There is no geographic monitoring, only how the driver is used when it is turned on, will be recorded. The driver has a lithium-ion battery and is charged via a normal wall charger, like a phone charger. It will need to be recharged on average every 2 weeks, for 4 hours.
Driver B: Automated Driver
A driver similar in shape to the current driver but only weighs 150 grams. It will be secured to the body via a stoma belt and will automatically turn on during the night to reinfuse chyme without requiring the participant to do anything. This driver will provide continuous refeeding and volume recording.

Once consented, taking part in this study will involve using the device for multiple 3-day trials consecutively over two weeks. The patient will complete 5x 3-day trials in total. There are allowances for patient schedules but as close to two weeks as possible.
• The participant will be given the option to insert the self-insertable tube into the stoma, but they do not have to, to take part in this study. If the participant wants to test the self-insertable tube, they will be supervised by the research nurse during this process. If the participant does not want to install the self-insertable tube, the tube and stoma bag will be fitted by the research nurse at either the participants home or in the clinic room.
• The participant will be taught how to use one of the drivers to reinfuse chyme and will be provided with the contact details of the research nurse and study investigator should they need to contact them at any time of day.
• The research nurse will contact The participant each day and will visit the day after insertion to watch a reinfusion and check it’s working well for the first two times.
• At the end of each trial (3 days), the research nurse will visit to remove the stoma bag and tube and replace it with a new one and ask The participant to fill in a one-page feedback form. The participant can provide verbal feedback at any time throughout the study. After the first 3-day trial, The participant can adjust the timing for subsequent trials so that they fit in with your lifestyle/work requirements. Visiting will be based on clinical need after the initial set-up and your independence grows with the device.
• After 2 weeks, you will be invited to continue trials up to stoma reversal. If the participant chooses to continue performing chyme reinfusion with the new version, they will continue to see the research nurse to provide more self-insertable tubes but the contact will be based on clinical need so will likely be less than during the trial period. Conversely, the participant is welcome to stop testing.



Intervention code [1] 327885 0
Treatment: Devices
Intervention code [2] 327886 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337267 0
Safety of a new version of The Insides System
Timepoint [1] 337267 0
Daily for 2 weeks from the start of the intervention.
Primary outcome [2] 337642 0
Efficacy of a new version of The Insides System
Timepoint [2] 337642 0
Daily for 2 weeks from the start of the intervention.
Secondary outcome [1] 431276 0
Patient usability of the device
Timepoint [1] 431276 0
Daily for 2 weeks from the start of the intervention.
Secondary outcome [2] 432673 0
Identify barriers to use of the device
Timepoint [2] 432673 0
Daily for 2 weeks from the start of the intervention.

Eligibility
Key inclusion criteria
• Adults >=18 years of age, with defunctioning loop/double barrel/abcarian small bowel stoma or enterocutaneous fistula
• If colonic anastomosis present, anastomotic leak and distal obstruction will be excluded e.g. via gastrografin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy
• If ECF patient, gastrografin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy to ensure patent distal intestine
• Distal limb of stoma can be intubated with a minimum of 22 Fr feeding tube (dilatation of stoma orifice strictures is allowable)
• Able to independently manage their stoma
• Proximal and distal outlets contained within one ostomy appliance
• Able to understand the risks/benefits of the study
• Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• <18 years of age
• Anastomotic leak or perforation
• Insufficient distal access or distal obstruction
• Current pregnancy
• Separated proximal and distal stomas that are pouched with separate ostomy appliances
• Unable understand the risks/benefits of the study and to give informed consent
• Unable to independently manage a stoma
• Inability to intubate the distal stoma
• Previous or current Clostridium difficile colitis

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
Feedback from patients and nurses improve and dictate device improvements and usability

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
50
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26130 0
New Zealand
State/province [1] 26130 0

Funding & Sponsors
Funding source category [1] 315723 0
Commercial sector/Industry
Name [1] 315723 0
The Insides Company
Country [1] 315723 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Insides Company
Address
Country
New Zealand
Secondary sponsor category [1] 317828 0
None
Name [1] 317828 0
Address [1] 317828 0
Country [1] 317828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314586 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314586 0
Ethics committee country [1] 314586 0
New Zealand
Date submitted for ethics approval [1] 314586 0
29/11/2023
Approval date [1] 314586 0
25/01/2024
Ethics approval number [1] 314586 0
2023 FULL 18323

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

Contacts
Principal investigator
Name 132098 0
Prof Ian Bissett
Address 132098 0
University of Auckland, 85 Park Road Grafton Auckland 1023
Country 132098 0
New Zealand
Phone 132098 0
+64093737599
Fax 132098 0
Email 132098 0
[email protected]
Contact person for public queries
Name 132099 0
Emma Ludlow
Address 132099 0
University of Auckland, 85 Park Road Grafton Auckland 1023
Country 132099 0
New Zealand
Phone 132099 0
+64 09 887 9309
Fax 132099 0
Email 132099 0
[email protected]
Contact person for scientific queries
Name 132100 0
Emma Ludlow
Address 132100 0
University of Auckland, 85 Park Road Grafton Auckland 1023
Country 132100 0
New Zealand
Phone 132100 0
+64 9 887 9309
Fax 132100 0
Email 132100 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
Privacy will be broken if their feedback is shared


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.