Rezum FIM Optimization (Rezum FIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02940392|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum||Device: Rezum System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2018|
Experimental: Rezum Treatment
Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.
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.
- Lesion Characteristics via MRI [ Time Frame: 1 week post procedure ]Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI
- Change in IPSS [ Time Frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years ]Change in IPSS score from Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
- Intra-procedure Pain [ Time Frame: Procedure day ]Procedural pain was assessed using the Wong Baker scale. Subjects were asked to rate the level of pain and discomfort during the treatment.
- Post-Procedure Catheterization [ Time Frame: 24 hours post procedure ]Post procedure catheterization documented
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940392
|La Romana, Dominican Republic|
|Study Director:||Cindy B Ogden||Vice President, Clinical Affairs - NxThera, Inc.|