Trial Outcomes & Findings for Radioprotective Light-weight Caps in the Interventional Cardiology Setting (NCT NCT01620658)
NCT ID: NCT01620658
Last Updated: 2022-03-07
Results Overview
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
COMPLETED
NA
197 participants
1 day
2022-03-07
Participant Flow
Patients presenting to the Miami Cardiac and Vascular Institute for Imaging Study/Procedure.
Voluntary patient participation. PI responsible for patient selection.
Participant milestones
| Measure |
Standard Cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
74
|
64
|
|
Overall Study
COMPLETED
|
35
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
24
|
29
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Baseline characteristics by cohort
| Measure |
Standard Cap
n=59 Participants
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
n=74 Participants
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
n=64 Participants
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=39 Participants
|
53 years
n=41 Participants
|
53 years
n=35 Participants
|
53 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
95 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
102 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=39 Participants
|
74 participants
n=41 Participants
|
64 participants
n=35 Participants
|
197 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Mean Radiation Protection is described under Outcome Measure Data below.
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
Outcome measures
| Measure |
Standard Cap
n=35 Participants
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
n=45 Participants
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
n=44 Participants
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
|---|---|---|---|
|
Radiation Attenuation in Percentage (%)
|
12 Percentage
Interval 4.9 to 19.1
|
91.5 Percentage
Interval 87.4 to 95.6
|
97.1 Percentage
Interval 92.5 to 100.0
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.
The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
Outcome measures
| Measure |
Standard Cap
n=35 Participants
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
n=45 Participants
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
n=44 Participants
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
|---|---|---|---|
|
Absolute Radiation Exposure Outside of Cap
|
132 uSv
Interval 21.0 to 243.0
|
118 uSv
Interval 54.0 to 183.0
|
59 uSv
Interval 33.0 to 85.0
|
SECONDARY outcome
Timeframe: 1 day per participant, a total of 197 operator daysAfter completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Outcome measures
| Measure |
Standard Cap
n=59 Participants
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
n=74 Participants
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
n=64 Participants
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
|---|---|---|---|
|
Operator Comfort Assessment
|
90 score on a scale
Interval 0.0 to 100.0
|
90 score on a scale
Interval 0.0 to 100.0
|
90 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 day per participant, a total of 197 operator daysAfter completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Outcome measures
| Measure |
Standard Cap
n=59 Participants
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
0.3mm XPF Cap
n=64 Participants
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
0.5mm XPF Cap
n=74 Participants
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
|
|---|---|---|---|
|
Operator Comfort Assessment Based on Weight
|
12.5 grams
Interval 12.5 to 12.6
|
123.7 grams
Interval 122.9 to 124.6
|
118.4 grams
Interval 116.7 to 120.3
|
Adverse Events
Standard Cap
0.3mm XPF Cap
0.5mm XPF Cap
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raul Herrera, MD. Director Miami Cardiac and Vascular Institute, Research and Outcomes
Baptist Health South Florida
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place