Trial Outcomes & Findings for Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) (NCT NCT01912339)

NCT ID: NCT01912339

Last Updated: 2020-04-13

Results Overview

Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).

Recruitment status

COMPLETED

Study phase

Target enrollment

197 participants

Primary outcome timeframe

3 Month Follow-up Visit

Results posted on

2020-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.	Crossover of Control Subjects Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
Blinded (0 to 3 Months) STARTED	136	61	0
Blinded (0 to 3 Months) COMPLETED	134	61	0
Blinded (0 to 3 Months) NOT COMPLETED	2	0	0
Unblinded (3 to 6 Months/Crossover) STARTED	134	61	0
Unblinded (3 to 6 Months/Crossover) COMPLETED	133	61	0
Unblinded (3 to 6 Months/Crossover) NOT COMPLETED	1	0	0
Unblinded (6 Months/Crossover to 5 Yrs) STARTED	133	0	53
Unblinded (6 Months/Crossover to 5 Yrs) COMPLETED	0	0	0
Unblinded (6 Months/Crossover to 5 Yrs) NOT COMPLETED	133	0	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Crossover of Control Subjects Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
Blinded (0 to 3 Months) Declined to participate	1	0
Blinded (0 to 3 Months) Open Prostatectomy	1	0
Unblinded (3 to 6 Months/Crossover) Withdrawal by Subject	1	0
Unblinded (6 Months/Crossover to 5 Yrs) Lost to Follow-up	5	0
Unblinded (6 Months/Crossover to 5 Yrs) Missed Visit	5	0
Unblinded (6 Months/Crossover to 5 Yrs) Withdrawal by Subject	1	3
Unblinded (6 Months/Crossover to 5 Yrs) BPH Medication	1	0
Unblinded (6 Months/Crossover to 5 Yrs) TURP/Laser	1	0
Unblinded (6 Months/Crossover to 5 Yrs) Physician Decision	0	1
Unblinded (6 Months/Crossover to 5 Yrs) Death	0	1
Unblinded (6 Months/Crossover to 5 Yrs) Subject started on Cialis	0	1
Unblinded (6 Months/Crossover to 5 Yrs) Had PVP - Prostate laser surgery	0	1
Unblinded (6 Months/Crossover to 5 Yrs) Still in Study	120	46

Baseline Characteristics

Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control n=61 Participants Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.	Total n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=99 Participants	36 Participants n=107 Participants	120 Participants n=206 Participants
Age, Categorical >=65 years	52 Participants n=99 Participants	25 Participants n=107 Participants	77 Participants n=206 Participants
Age, Continuous	63.0 years STANDARD_DEVIATION 7.1 • n=99 Participants	62.9 years STANDARD_DEVIATION 7.0 • n=107 Participants	62.9 years STANDARD_DEVIATION 7.0 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	136 Participants n=99 Participants	61 Participants n=107 Participants	197 Participants n=206 Participants
Region of Enrollment United States	136 participants n=99 Participants	61 participants n=107 Participants	197 participants n=206 Participants

PRIMARY outcome

Timeframe: 3 Month Follow-up Visit

Population: Intention to Treat population (ITT)

Outcome measures

Outcome measures
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control n=61 Participants Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up	-11.2 Cange in IPSS score Interval -12.5 to -9.9	-4.3 Cange in IPSS score Interval -6.1 to -2.5

PRIMARY outcome

Timeframe: 3 Months

Population: Intention to Treat population (ITT) for treatment arm subjects only. Control subjects did not undergo a treatment procedure so they were not assessed for this endpoint.

This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months. Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint.

Outcome measures

Outcome measures
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Safety: Device Related Serious Complications	1 Participants Interval 0.0 to 4.6	—

SECONDARY outcome

Timeframe: 3 Months

Population: Intention to Treat population (ITT)

Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control n=61 Participants Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Responders at 3 Months	106 Participants	21 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.

Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Responders at 6 Months	102 Participants	—

SECONDARY outcome

Timeframe: 12 Months

Population: Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.

Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=136 Participants Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Responders at 12 Months	104 Participants	—

Adverse Events

Treatment

Serious events: 18 serious events

Other events: 66 other events

Deaths: 0 deaths

Control

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Treatment n=136 participants at risk Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control n=61 participants at risk Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
Renal and urinary disorders Dysuria	16.9% 23/136 • Number of events 24 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	1.6% 1/61 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Hematuria, Gross	12.5% 17/136 • Number of events 17 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Reproductive system and breast disorders Hematospermia	7.4% 10/136 • Number of events 10 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Urinary, Frequency	6.6% 9/136 • Number of events 9 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	3.3% 2/61 • Number of events 2 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Urinary Urgency	5.9% 8/136 • Number of events 8 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	1.6% 1/61 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).

Additional Information

Kevin Hagelin, Clinical Program Manager

Boston Scientific Corporation

Phone: (800) 328-3881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Treatment n=136 participants at risk Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response.	Control n=61 participants at risk Control: Rigid Cystoscopy Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra.
General disorders Nausea	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
General disorders Vomiting	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Urinary Retention	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders UTI, Culture Proven	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Gastrointestinal disorders Bowel Obstruction	1.5% 2/136 • Number of events 3 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Musculoskeletal and connective tissue disorders Injury, other (fractured ribs)	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Respiratory, thoracic and mediastinal disorders Pneumonia	1.5% 2/136 • Number of events 2 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	3.3% 2/61 • Number of events 2 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, other	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Vascular disorders Hemorrhoids	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Infections and infestations Infection (other than UTI)	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	1.6% 1/61 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Vascular disorders Other - Atherosclerotic Artery Disease	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Musculoskeletal and connective tissue disorders Other, Broken Right Thumb	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Pyelonephritis	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
Nervous system disorders Spinal Stenosis	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	0.00% 0/61 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).
General disorders Syncope	0.74% 1/136 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).	1.6% 1/61 • Number of events 1 • 1 year,10 months Within 1 year and 10 months of first enrollment (average Treatment group follow-up of 16.4 months, average Control group follow-up of 4.7 months). Procedure relatedness was adjudicated by an independent Clinical Events Committee (CEC).