Assessing the Safety and Efficacy of the ClearRing™ Implant for the Treatment of Benign Prostatic Hyperplasia in a Canine Model
Bibliographic record
Abstract
BACKGROUND: Transurethral resection of the prostate is the most common procedure for the treatment of benign prostatic hyperplasia (BPH). Although effective, transurethral resection of the prostate can be associated with side effects including prolonged recovery, storage and voiding symptoms, risk of acute urinary retention. OBJECTIVES: In this study, we describe a new minimally invasive device for the treatment of lower urinary track symptoms due to BPH, implanting a nitinol C shape ring in a circular incision in the prostatic tissue, surrounding the urethra, done by electrocuting blade over a dilatation balloon. METHODS: Two groups of dogs (4/ group) were implanted with the device under anesthesia. Clinical observation, body weight and weekly blood and urinary tests were performed throughout the study period to evaluate safety. Fluoroscopy and cystoscopy were used throughout the study period to evaluate implant condition and urethral dilatation. At the end of 3 weeks (Group I) or 3 months (Group II), the animals were sacrificed. The implantation site was examined macroscopically and histologically to evaluate urethral dilatation and tissue response. RESULTS: The presence of the ClearRing™ implant in an animal's prostate was associated with significant dilatation of the prostatic urethra. Fever, pain, behavior disturbances or gross hematuria, when occurred, resolved within 72 hours post procedure and no severe adverse events were observed. There was no evidence of prostatic hyperplasia associated to ring implantation. Partial epithelial coverage of the implant surface was observed without evidence of encrustation. CONCLUSION: The ClearRing™ implant seems a feasible minimally invasive procedure for relieving lower urinary track symptoms due to BPH.
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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".