Trials / Completed
CompletedNCT03372096
LC Bead LUMI for Prostatic Artery Embolization
LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Detailed description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Prostatic Artery Embolization | LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. |
Timeline
- Start date
- 2018-07-13
- Primary completion
- 2020-09-03
- Completion
- 2020-09-03
- First posted
- 2017-12-13
- Last updated
- 2021-02-24
- Results posted
- 2021-02-05
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03372096. Inclusion in this directory is not an endorsement.