Trial Outcomes & Findings for Radiofrequency (RF) Ablation Prospective Outcomes Study (NCT NCT04673032)
NCT ID: NCT04673032
Last Updated: 2026-04-15
Results Overview
Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline
Recruitment status
COMPLETED
Target enrollment
298 participants
Primary outcome timeframe
12-months post-procedure
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
Boston Scientific Radiofrequency Ablation Systems
Subjects with pain treated with a commercially approved Boston Scientific RF system
Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
COMPLETED
|
225
|
|
Overall Study
NOT COMPLETED
|
73
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency (RF) Ablation Prospective Outcomes Study
Baseline characteristics by cohort
| Measure |
Boston Scientific Radiofrequency Ablation Systems
n=294 Participants
Subjects with pain treated with a commercially approved Boston Scientific RF system
Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain
|
|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 12.9 • n=193 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
1 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Black, of African heritage
|
15 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
White
|
235 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
1 participants in category
n=193 Participants
|
|
Race/Ethnicity, Customized
Data Missing
|
28 participants in category
n=193 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=193 Participants
|
|
Region of Enrollment
Belgium
|
18 participants
n=193 Participants
|
|
Region of Enrollment
United States
|
263 participants
n=193 Participants
|
|
Numeric Rating Scale
|
6.5 units on a scale
STANDARD_DEVIATION 1.9 • n=193 Participants
|
PRIMARY outcome
Timeframe: 12-months post-procedureUsing the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline
Outcome measures
| Measure |
Boston Scientific Radiofrequency Ablation Systems
n=223 Participants
Subjects with pain treated with a commercially approved Boston Scientific RF system
Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain
|
|---|---|
|
Patient Global Impression of Change (PGIC)
Very much worse
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Improved
|
66 Participants
|
|
Patient Global Impression of Change (PGIC)
Much Improved
|
78 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Improved
|
54 Participants
|
|
Patient Global Impression of Change (PGIC)
No change
|
13 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally worse
|
9 Participants
|
|
Patient Global Impression of Change (PGIC)
Much worse
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-months post-procedurePercentage of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity
Outcome measures
| Measure |
Boston Scientific Radiofrequency Ablation Systems
n=206 Participants
Subjects with pain treated with a commercially approved Boston Scientific RF system
Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain
|
|---|---|
|
Responder Rate
|
135 Participants
|
Adverse Events
Boston Scientific Radiofrequency Ablation Systems
Serious events: 44 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Boston Scientific Radiofrequency Ablation Systems
n=298 participants at risk
Subjects with pain treated with a commercially approved Boston Scientific RF system
Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.67%
2/298 • Number of events 2 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Abdominal infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Abscess limb
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Arthritis bacterial
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Nervous system disorders
Nerve compression
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Bacterial infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Device related infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Gastrointestinal infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Haematoma infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Localised infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Mastitis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Meningitis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Post procedural pneumonia
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Infections and infestations
Post Wound Infection
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
4/298 • Number of events 4 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.67%
2/298 • Number of events 2 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Cardiac disorders
Coronary Artery disease
|
0.67%
2/298 • Number of events 2 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Post Procedural complication
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Nervous system disorders
Seizure
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Nervous system disorders
Somnolence
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.67%
2/298 • Number of events 2 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
Haematuria
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Ear and labyrinth disorders
Vertigo
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Respiratory, thoracic and mediastinal disorders
Pumonary embolism
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Eye disorders
Ostic ischaemic neuropathy
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
|
Vascular disorders
Thrombosis
|
0.34%
1/298 • Number of events 1 • From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
|
Other adverse events
Adverse event data not reported
Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER