RecruitingOBSERVATIONAL

Analytical Validation of Stream™ Platform

This study is checking a new medical system called Stream™. It includes a device called Origin™ that measures the acidity (pH) of fluid draining from your tummy after surgery. This information is really important because changes in acidity can be an early sign of problems like infections. We want to make sure the Origin™ device gives accurate and reliable results. Researchers will be testing its precision, checking if it measures correctly across different acidity levels, and comparing it to other standard ways of measuring pH. They will use special testing liquids and fluid samples collected from patients who have had surgery on their tummy, including those for bowel, liver, or injury-related operations.

At a glance

Status

Recruiting

Sponsor

FluidAI Medical

Enrolment target

Start

19 Nov 2024

Estimated completion

01 Jul 2025

Gastrointestinal Diseases

What is this study about?

Imagine you've just had surgery on your tummy, perhaps for something like bowel issues or an injury. After this kind of operation, doctors sometimes place a small tube, called a drain, to collect any extra fluid. The clever people behind the Stream™ Platform have developed a new device called Origin™ that can be connected to this drain. Its job is to constantly check how acidic or alkaline (known as pH) this drainage fluid is. Why is pH important? Well, changes in the fluid's acidity can be a very early warning sign that something isn't right, like an infection, giving doctors a heads-up to act quickly.

This particular study isn't looking at patients directly but is focused on making sure this new Origin™ device works perfectly. Think of it like putting a brand-new measuring tape through some rigorous tests to see if it always gives the correct length. The researchers will be checking things like how precise the device is (does it give the same reading every time for the same sample?), how well it measures different acidity levels, and whether anything else in the fluid could unexpectedly affect its readings. They'll also compare its results with older, trusted methods to be absolutely sure it's accurate.

To do this, they will use special liquids made for testing and also collect small amounts of the drainage fluid from patients who have had tummy surgery. This includes patients who've had operations on their bowel, liver, or those who've had surgery after an injury. The goal is to make sure that when the Stream™ Platform is eventually used more widely, doctors can completely trust the pH readings it provides, helping them look after patients even better.

Key takeaways

This study evaluates a new device, Origin™, for measuring drainage fluid acidity.
Accurate measurements help doctors detect post-surgery complications early.
Participation involves only collecting existing drainage fluid samples.
There are no direct risks or personal benefits for participants.
No personal health information will be collected.
Your involvement finishes when you leave hospital or your drain is removed.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old, whether you are male or female. It's really important that you understand what the study involves and are happy to sign a consent form, showing you agree to take part. You also need to be willing to follow all the study instructions.

Critically, you must have recently undergone an operation on your tummy or pelvic area, either open surgery or keyhole surgery, and currently have a drain in place to collect fluid from your abdomen.

However, there are a few reasons you wouldn't be able to take part. For example, if you are expected to leave the hospital less than 8 hours after your surgery, this study isn't for you. Also, if you have certain infections like Hepatitis B or C, HIV, TB, or infections caused by germs resistant to many medicines, you wouldn't be eligible. Lastly, if you were involved in planning or setting up this specific study, you cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had surgery on your tummy or pelvis recently, with a drain in place?
Are you happy to sign a form agreeing to take part and follow study rules?
Are you not expected to leave the hospital within 8 hours of your surgery?
Do you not have certain infectious diseases like Hepatitis, HIV, or multi-drug resistant infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the process is very simple and will not involve any extra visits or changes to your hospital stay. All that's required is for a small sample of the fluid from your existing abdominal drain to be collected once a day. This fluid is usually thrown away anyway, as it's considered a waste product. Your personal health information won't be collected, and you won't need any follow-up after the study.

Your involvement will automatically end when you are discharged from the hospital, or when your surgeon decides to remove your abdominal drain, whichever happens first. There are no medications involved in this study, and no extra assessments will be performed on you.

Potential risks and benefits

This study carries no direct risks to you as a participant. It only involves collecting a small amount of fluid from a drain that's already in place, and this fluid would otherwise be discarded. No personal information is gathered, and no extra procedures will be performed on you. There are no direct benefits to you personally from taking part in this specific study, as its aim is to test the device for future patient care. However, by participating, you would be contributing to the advancement of medical technology, which could help many patients in the future by allowing doctors to spot potential complications earlier. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Juravinski Hospital
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to check if a new device, Origin™, can accurately and reliably measure the acidity of fluid draining from your tummy after surgery.

Will I have to do anything extra if I join?

No, you won't. The study only involves collecting a small amount of fluid from your existing drainage tube once a day, which is usually discarded anyway.

Will this study affect my medical care?

No, taking part in this study will not affect your medical care in any way. It's focused on testing the device, not on your treatment.

Is my personal information safe?

Yes, completely. No personal health information is collected from participants for this study.

Will I get any benefit from taking part?

While there's no direct personal benefit, your participation helps improve medical tools for future patients by ensuring new devices are accurate and safe.

How to find out more

Dr Pablo Serrano, MD MPH FACS

serrano@mcmaster.ca (905) 521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.