Trial Outcomes & Findings for An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres (NCT NCT04272216)
NCT ID: NCT04272216
Last Updated: 2025-09-09
Results Overview
Defined as completing the planned procedure without femoral access bailout
Recruitment status
COMPLETED
Target enrollment
99 participants
Primary outcome timeframe
Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
16
|
7
|
6
|
|
Overall Study
COMPLETED
|
45
|
8
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
25
|
8
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
Baseline characteristics by cohort
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 Participants
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 Participants
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 Participants
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 Participants
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
n=5 Participants
|
67.6 years
n=7 Participants
|
59.6 years
n=5 Participants
|
60.3 years
n=4 Participants
|
50.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
16 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
Medical History
Myocardial Infarction (MI)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Medical History
Atrial Fibrillation
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Medical History
Hypertension
|
26 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Medical History
Hypercholesterolemia
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))Defined as completing the planned procedure without femoral access bailout
Outcome measures
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 Participants
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 Participants
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 Participants
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 Participants
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Procedural Success
|
70 Participants
|
16 Participants
|
7 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Outcome measures
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 Participants
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 Participants
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 Participants
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 Participants
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Technical Success
Successful delivery of HydroPearls to target vessels
|
69 Participants
|
16 Participants
|
7 Participants
|
6 Participants
|
|
Technical Success
Complete Embolization
|
69 Participants
|
14 Participants
|
7 Participants
|
6 Participants
|
|
Technical Success
Partial Embolization
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: within 30 days post-procedureMajor Adverse Events are defined as the following: Death MI Stroke
Outcome measures
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 Participants
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 Participants
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 Participants
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 Participants
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Freedom From Major Adverse Events and Radial Access Complications
Stroke within 30 days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Freedom From Major Adverse Events and Radial Access Complications
Freedom from Major Adverse Events and radial access complications within 30 days post procedure
|
69 Participants
|
16 Participants
|
6 Participants
|
6 Participants
|
|
Freedom From Major Adverse Events and Radial Access Complications
Death within 30 days
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Freedom From Major Adverse Events and Radial Access Complications
MI within 30 days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post procedureRadial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure
Outcome measures
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 Participants
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 Participants
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 Participants
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 Participants
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Radial Access Related Complications Within 30 Days
Finger amputation/ loss of limb
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Vessel occlusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Hand Ischemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Arteriovenous fistula
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Pseudoaneurysm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Vessel dissection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Vessel spasm
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Radial Access Related Complications Within 30 Days
Artery perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Distal embolization
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radial Access Related Complications Within 30 Days
Hematoma at the puncture site
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Radial Access Related Complications Within 30 Days
Access site pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Radial Access Related Complications Within 30 Days
Other
|
8 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Uterine Fibroid Embolization With HydroPearls Via Radial Access
Serious events: 6 serious events
Other events: 32 other events
Deaths: 1 deaths
Prostatic Artery Embolization With HydroPearls Via Radial Access
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Liver Tumor Embolization With HydroPearls Via Radial Access
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 participants at risk
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 participants at risk
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 participants at risk
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 participants at risk
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Hepatobiliary disorders
Death
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Blood and lymphatic system disorders
Blood loss anemia
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
33.3%
2/6 • Number of events 2 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Infections and infestations
Corona Virus
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Post-procedural complication
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Infections and infestations
Septic Shock
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Infections and infestations
Enterococcal bacteremia
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
Other adverse events
| Measure |
Uterine Fibroid Embolization With HydroPearls Via Radial Access
n=70 participants at risk
Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access.
|
Prostatic Artery Embolization With HydroPearls Via Radial Access
n=16 participants at risk
Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access.
|
Liver Tumor Embolization With HydroPearls Via Radial Access
n=7 participants at risk
Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access
n=6 participants at risk
Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
15.7%
11/70 • Number of events 11 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 2 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Nausea
|
10.0%
7/70 • Number of events 7 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 2 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
33.3%
2/6 • Number of events 2 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
4/70 • Number of events 4 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
5.7%
4/70 • Number of events 4 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
5/70 • Number of events 5 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
28.6%
2/7 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
General disorders
Peripheral swelling
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
General disorders
Pyrexia
|
0.00%
0/70 • Within 30 days of index procedure
|
12.5%
2/16 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
18.8%
3/16 • Number of events 3 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
4.3%
3/70 • Number of events 3 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/70 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/70 • Within 30 days of index procedure
|
12.5%
2/16 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/70 • Within 30 days of index procedure
|
12.5%
2/16 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/70 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.00%
0/70 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hematoma
|
0.00%
0/70 • Within 30 days of index procedure
|
6.2%
1/16 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Vascular disorders
Arterial Spasm
|
1.4%
1/70 • Number of events 1 • Within 30 days of index procedure
|
12.5%
2/16 • Number of events 2 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Post embolization syndrome
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
14.3%
1/7 • Number of events 1 • Within 30 days of index procedure
|
0.00%
0/6 • Within 30 days of index procedure
|
|
Injury, poisoning and procedural complications
Vascular access site erythema
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Investigations
Ammonia increased
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Investigations
Weight decreased
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.4%
1/70 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/70 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
|
Vascular disorders
Vasospasm
|
2.9%
2/70 • Number of events 2 • Within 30 days of index procedure
|
0.00%
0/16 • Within 30 days of index procedure
|
0.00%
0/7 • Within 30 days of index procedure
|
16.7%
1/6 • Number of events 1 • Within 30 days of index procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place