Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenoma

Hypertrophy

Prostatic Hyperplasia

Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

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.

Rezum System

Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

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.

Rezum FIM Optimization Study

Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System

Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure.

All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded.

Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.

Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated.

Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in prostate volume was calculated.

Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in transition (TZ) zone volume was calculated

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated.

The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure.

Boston Scientific Corporation

AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC).

51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.

Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.

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.

Rezum Treatment

Age, Continuous

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

Dominican Republic

Region of Enrollment

Director, Clinical Operations

IPSS Change at 1 Week

IPSS Change at 1 Month

IPSS change at 3 months

IPSS change at 6 months

IPSS change at 12 months

IPSS change at 24 months

IPSS change at 36 months

IPSS change at 48 months

IPSS change at 60 months

Mean change in score was calculated for the number of subjects providing data at each follow-up visit.

Change in International Prostate Symptom Score

average pain score post-procedure (day of procedure)

average pain 1 day post-procedure

average pain 1 week post-procedure

average pain 1 month post-procedure

average pain 3 months post-procedure

average pain 6 months post-procedure

Pain score was not collected for 1 subject at each of the following visits: 1 day, 3 month, and 6 month

Intra-procedural and Post-procedural Pain

Subjects catheterized at 1 day post procedure

Subjects catheterized at 1 week post procedure

Subjects catheterized at 1 month post procedure

Number of subjects requiring post-procedure catheterization. Two (2) subjects were catheterized prior to the Rezūm study enrollment and treatment. The decision was made to move forward with treating both subjects. All subjects were observed for 24 hours in the clinic post-procedure. Post-procedure catheterization was allowed if determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.

Number of Subjects Requiring Catheterization Post Procedure

Overall catheterization duration (days) per subject

Overall catheterization duration (days) per episode (13 episodes in 10 subjects)

Data provided for subjects who underwent the Rezūm ablation procedure.

Post Procedure Catheterization Duration

Mean percent change from 1 week to 1 month

Mean percent change from 1 week to 3 months

Mean percent change from 1 week to 6 months

One subject (each) did not have MRI available at the 3 month and 6 month follow-up visit.

Lesion Characteristics Via MRI (Changes in Lesion Volume)

One subject (each) did not have MRI data available at the 3 month and 6 month visit

Lesion Characteristics Via MRI (Changes in Prostate Volume)

One subject (each) did not have MRI available at the 3 month and 6 month visit

Spots Global Cancer Trial Database for Rezum FIM Optimization Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial