RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures (NCT04821739) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
Germany, Spain100 participantsStarted 2021-05-19
Plain-language summary
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
Who can participate
Age range
50 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
. Subject is a male or female 50 years of age or older at time of study treatment.
. Criterion omitted
. Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
. This VCF meets all of the following criteria:
. Fracture due to diagnosed or presumed underlying osteoporosis
. VCF from T1 to L5 inclusive
. Fracture age ≤6 months at time of treatment
. Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.
Exclusion criteria
. Target VCF is due to underlying or suspected tumor.
. Target VCF is due to high-energy trauma.
. Target VCF is diagnosed as an osteonecrotic fracture.
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.