Rezum I Pilot Study for BPH (Rezum Pilot)
|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: NCT02943070|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia 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 :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||December 2018|
Experimental: Rezum Treatment
Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.
Device: Rezum System
The Rezūm System treats 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.
- IPSS Improvement [ Time Frame: 3 months ]The change (improvement) from baseline in IPSS score.
- Major Complications [ Time Frame: 3 months ]
Safety is assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure).
The device related complications that will be compared for this safety endpoint are:
- Severe Urinary Retention (Retention ≥ 24 hours)
- Fistula between rectum and urethra
- Perforation of the rectum or GI tract
- New incidences of retrograde ejaculation
- Proportion of Responders wth a ≥ 30% IPSS Iimprovement [ Time Frame: 3 months ]The proportion of responders in the treatment and control arms will be evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS4.
- Proportion of Responders wth a ≥ 50% IPSS Iimprovement [ Time Frame: 3 months ]Analysis will be provided for a proportion of subjects with improvement ≥ 50% from baseline at 1 week, 1 month, and 3 months
- Proportion of Responders with improvement ≥ 8 points in IPSS [ Time Frame: 3 months ]Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months
- Change in Uroflow (Qmax) [ Time Frame: 1 year ]
Change in Uroflow at 1 year
• Peak urinary flow rate (Qmax)
- Change in Sexual Function [ Time Frame: 1 year ]
This will be measured by the following:
- Erectile Function as Measured by the International Index of Erectile Function (IIEF)
- Retrograde ejaculation
- Procedural Pain Score [ Time Frame: 1 month ]Subject will be asked to evaluate the level of pain experienced during the procedure, and at 1 day, 1 week, and 1 month post treatment. Pain score will be measured using the Wong-Baker scale.
- Quality of Life [ Time Frame: 1 year ]QoL will be measured using the QoL question in the IPSS
- Subject Satisfaction [ Time Frame: 1 year ]
This will be assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months and 1 year.
These will be measured as:
- Proportion of subjects that are satisfied with the procedure overall
- Proportion of subjects that would recommend this treatment to friends and families
- Proportion of subjects that would undergo the same treatment if their symptoms were to recur after 5 years
- Procedural Parameters [ Time Frame: Day 1 ]• Procedure time : Time from Delivery Tool insertion to final Delivery Tool withdrawal
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): NCT02943070
|Brno, Czech Republic|
|La Romana, Dominican Republic|
|Study Director:||Cindy B Ogden||Vice President, Clinical Affairs - NxThera, Inc.|