Prospective Evaluation of the LithoVue Elite Ureteroscope
This study is checking a new type of flexible tube, called the LithoVue Elite, which doctors use to treat kidney stones. Many people have kidney stones removed this way. The LithoVue Elite is a disposable tube designed to help doctors see and remove stones. This research aims to understand how well this new tube works compared to existing methods. They will look at whether it causes less pain, how it affects a patient's daily life, and if it leads to fewer problems like infections. Around 150 patients across six hospitals will take part to help evaluate this new treatment option.
At a glance
What is this study about?
When people have kidney stones, doctors often use a procedure called ureteroscopy. This involves inserting a very thin, flexible tube, called a ureteroscope, to find and remove the stones. There are different types of these tubes, some are reused after being sterilised, and some are thrown away after just one use. This new study is looking at a disposable tube called the LithoVue Elite, which has some new features.
The main goal of this study is to see how well the LithoVue Elite works in real-life situations. Doctors want to make sure it's as good as, or even better than, the tubes they currently use. They will be checking if it successfully clears kidney stones, if patients need fewer extra treatments afterwards, and how doctors feel about using it during the procedure.
Another important part of the study is to understand how the pressure inside the kidney during the procedure might affect patients. Researchers will investigate if higher pressure leads to more pain after the surgery, if it impacts a person's quality of life, or if it increases the risk of infections. By gathering all this information, doctors hope to learn if the LithoVue Elite can improve the way kidney stones are treated.
Key takeaways
- This study is testing a new, single-use device for removing kidney stones.
- It aims to see if the new device works as well as current methods and if it affects pain or quality of life.
- Around 150 patients across six UK hospitals will take part.
- You must be over 18 years old and have kidney stones less than 2cm.
- Participation involves questionnaires and follow-up after your standard surgery.
Who may be eligible?
This study is looking for adults aged 18 or older who are scheduled to have kidney stone removal surgery using a flexible tube and laser (called ureteroscopy and laser lithotripsy).
To be eligible, your kidney stone (or all your stones combined) must be 2 centimetres (about the size of a large pea) or smaller. You can't take part if you are pregnant, have a tube already placed in your kidney (a nephrostomy tube), or have kidney problems that might make it difficult to clear all the stones. Also, if your kidney is very swollen, you might not be able to join.
The study welcomes people who are having treatment for stones in both kidneys at the same time. If you fit these descriptions, your doctor might ask you if you'd like to 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?
- Are you having surgery for kidney stones using a laser and flexible tube?
- Are your kidney stones 2cm (about the size of a large pea) or smaller?
- Are you not pregnant?
- Do you not have a tube already in your kidney (nephrostomy tube)?
What does participation involve?
If you agree to join the study, you'll first have some standard checks like scans and urine tests. You'll also fill out two questionnaires about your pain levels and how kidney stones affect your daily life. Before your procedure, you'll have a urine test, and if needed, a urine culture to check for infection.
During your kidney stone removal surgery, which will be carried out as usual by your doctor, they will use the new LithoVue Elite tube. The study will mainly observe how this new tube performs during your standard procedure. After your surgery, you'll complete the same questionnaires again to see if your pain or quality of life has changed. You'll also have a follow-up scan about 4 to 8 weeks after your procedure to check if all the stones have been cleared. The total duration of the study activities for you will be from when you agree to participate until your follow-up scan.
Potential risks and benefits
Locations (6)
- Vancouver General HospitalVerified postcodeVancouver, Canada· Not yet recruiting
- Western UniversityVerified postcodeLondon, Canada· Not yet recruiting
- Centre Hospitalier de l'Université de Montréal (CHUM)Verified postcodeMontreal, Canada· Recruiting
- Hôpital Maisonneuve-Rosemont (HMR)Verified postcodeMontreal East, Canada· Not yet recruiting
- CHU de Québec-Université LavalVerified postcodeQuébec, Canada· Not yet recruiting
- University of SaskatchewanVerified postcodeSaskatoon, Canada· Not yet recruiting
Common questions
What is a ureteroscope?
It's a thin, flexible tube that doctors use to look inside the urinary tract and remove kidney stones.
What's special about the LithoVue Elite?
It's a new disposable tube that might have features to help doctors during kidney stone removal, such as sensing pressure.
Will I get special treatment in this study?
You'll receive your planned kidney stone removal surgery as normal, but your doctor will use the new LithoVue Elite tube.
Will I have more hospital visits?
You'll have your usual check-ups, plus some questionnaires and possibly an extra scan or urine test for the study.
Can I leave the study if I change my mind?
Yes, you can decide to stop participating at any point, and it won't affect your medical care.
How to find out more
Naeem Dr Bhojani, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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