Exploratory Investigation on a Novel Catheter (NCT05644912) | Clinical Trial Compass
CompletedNot Applicable
Exploratory Investigation on a Novel Catheter
Netherlands13 participantsStarted 2022-11-18
Plain-language summary
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of informed consent.
. Female and male aged 18-80 years.
. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
. Patients considered suitable to participate by investigator.
. Able to read, write and understand information given to them regarding the study.
Exclusion criteria
. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Previous enrolment in the present clinical investigation.
. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.