AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Benign Prostate Hyperplasia, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 50 - 80 |
| Updated: | 5/26/2017 |
| Start Date: | December 14, 2014 |
| End Date: | April 27, 2017 |
PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
The primary objective of this study is to evaluate the safety and performance of the
AQUABEAM® System device for the treatment of lower urinary tract symptoms associated with
BPH
AQUABEAM® System device for the treatment of lower urinary tract symptoms associated with
BPH
The primary safety endpoint of the study is the perioperative complication rate.
Complications will be divided into those that are serious vs. non-serious based on the above
definitions and reviewed by an independent assessor
Secondary endpoints include:
- Change from baseline in IPSS, IIEF
- Change from baseline in peak urinary flow rate, post-void residual volume and
- PDet@Qmax (Schaffer grade)
Complications will be divided into those that are serious vs. non-serious based on the above
definitions and reviewed by an independent assessor
Secondary endpoints include:
- Change from baseline in IPSS, IIEF
- Change from baseline in peak urinary flow rate, post-void residual volume and
- PDet@Qmax (Schaffer grade)
Inclusion Criteria:
- Male
- 50 - 80 years
- Moderate to severe BPH
- Subjects who have failed standard medical therapy
Exclusion Criteria:
- Size and width of prostate
- Medical condition or co-morbidities where BPH intervention would be contraindicated
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