N/A
Completed N=20
Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Treatment of Benign Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT02683980 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Ablation Time — 36.0 Minutes
Summary
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.
The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ablation Time |
36.0 | — |
| PRIMARY Ablation Rate |
0.4 | — |
| PRIMARY Efficiency of the Laser to Ablate the Prostate |
9.4 | — |
| PRIMARY Safety: Intraoperative Complications |
1; 0; 0; 3; 0 | — |
| PRIMARY Safety: Perioperative Complications |
2; 0; 1; 1; 1; 1 | — |
| SECONDARY Erectile Dysfunction |
6.1; 8.9 | — |
| SECONDARY Visibility During Procedure |
0; 0; 4; 7; 9 | — |
| SECONDARY Number of Fibers Used During Procedure |
17; 3; 0 | — |
| SECONDARY Catheterization Time |
3; 16; 1 | — |
| SECONDARY Hospital Stay Duration |
20; 0 | — |
| SECONDARY International Prostate Symptom Score Quality of Life |
3.4; 2.6; 1.9 | — |
| SECONDARY Qmax Uroflow |
7.3; 12.8; 9.4 | — |
| SECONDARY PVR (Post-void Residual) |
63.0; 44.9; 55.9 | — |
| SECONDARY PSA (Prostate-specific Antigen) |
2.1; 2.1 | — |
| SECONDARY Americal Urological Association (AUA) Symptom Index |
18.4; 13.8; 10.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject will be older than 18 years of age
- Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
- Subject is a candidate for surgery treatment
- Subject is willing and has signed the Informed Consent Form
- AUA score ≥ 12
- Qmax 300 mL
- Current Urine retention and Pdet <40 cm H20
- Documented or suspected prostate cancer and / or bladder cancer
- Neurogenic bladder disorder / neurogenic voiding dysfunction
- Urethral strictures
- Previous prostatic, bladder neck, or urethral surgery
- Known history of spinal cord injury
- Urogenital trauma
- Bladder neck stricture
- Evidence of urinary tract infection
- History of chronic prostatitis
Data sourced from ClinicalTrials.gov (NCT02683980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.