Trials / Completed
CompletedNCT02940392
Rezum FIM Optimization Study
Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
Detailed description
Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.
Conditions
- Benign Prostatic Hyperplasia
- Adenoma, Prostatic
- Prostatic Adenoma
- Prostatic Hyperplasia, Benign
- Prostatic Hypertrophy
- Prostatic Hypertrophy, Benign
- Rezum
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rezum System | The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. |
Timeline
- Start date
- 2012-03-19
- Primary completion
- 2017-05-19
- Completion
- 2017-05-19
- First posted
- 2016-10-20
- Last updated
- 2021-03-05
- Results posted
- 2021-03-05
Locations
1 site across 1 country: Dominican Republic
Source: ClinicalTrials.gov record NCT02940392. Inclusion in this directory is not an endorsement.