Feasibility and safety study of the Flostent™ system (RAPID-I)
Bibliographic record
Abstract
INTRODUCTION: This study aimed to evaluate the feasibility and safety of the FloStent™, a novel nitinol prostatic stent, in men with LUTS secondary to BPH. MATERIALS AND METHODS: This multi-center, single-arm, one-year study included men aged ≥45 with BPH. Participants underwent FloStent™ implantation using a flexible cystoscope. The primary endpoints were device implantability, tolerability, and device retrievability. Secondary assessments included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR), and adverse events (AEs) at follow-ups over 52 weeks. RESULTS: The study enrolled 15 participants with a mean age of 58.1 years. All attempts at implantation were successful. Postoperative catheterization was not required in any patient. Significant improvements were observed in IPSS and Qmax. Thirteen AEs were reported, all resolved, with no serious complications. Device retrieval was safely performed using standard urological equipment up to one-year post-implantation. CONCLUSIONS: This preliminary study indicates that the FloStent™ is a safe and effective treatment option for BPH, providing significant symptom relief and improved urinary function with a favorable risk profile. Further research, including larger, randomized controlled trials, are needed to validate these findings and establish the long-term efficacy and safety of the FloStent™ device.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".