Trial Outcomes & Findings for Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (NCT NCT04404257)

Results Overview

Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

170 participants

Primary outcome timeframe

During each cardiac catheterization, an average of 90 minutes

Results posted on

2023-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	ControlRad System Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.	Without ControlRad System Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
Overall Study STARTED	85	85
Overall Study COMPLETED	85	85
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ControlRad System n=85 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.	Without ControlRad System n=85 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	Total n=170 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 4.6 • n=85 Participants	57.1 years STANDARD_DEVIATION 9.9 • n=85 Participants	63.7 years STANDARD_DEVIATION 1.2 • n=170 Participants
Sex: Female, Male Female	35 Participants n=85 Participants	36 Participants n=85 Participants	71 Participants n=170 Participants
Sex: Female, Male Male	50 Participants n=85 Participants	49 Participants n=85 Participants	99 Participants n=170 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	85 participants n=85 Participants	85 participants n=85 Participants	170 participants n=170 Participants

PRIMARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad

Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization	39 microsievert Interval 19.0 to 61.0	18 microsievert Interval 7.0 to 35.0

PRIMARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization	41 microsievert	18 microsievert

PRIMARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Primary Operator, EP Procedure (Luxel)	58.1 microsieverts	21.7 microsieverts

PRIMARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes duration

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.

Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Primary Operator, EP Procedure (RaySafe)	61 microsieverts Interval 25.5 to 149.0	25 microsieverts Interval 15.0 to 69.5

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad

Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)	21 microsievert Interval 13.0 to 49.0	12 microsievert Interval 6.0 to 22.0

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization	26 microsievert	13 microsievert

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad

Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)	NA microsievert Dosage data unreliable as it is below lower limits of detection	NA microsievert Dosage data unreliable as it is below lower limits of detection

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad

Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)	NA microsievert Dosage data unreliable as it is below lower limits of detection	NA microsievert Dosage data unreliable as it is below lower limits of detection

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad

Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy\*m\^2.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Patient, Cardiac Catheterization	3487 μGy*m^2 Interval 2257.0 to 5977.0	2276 μGy*m^2 Interval 1179.0 to 3321.0

SECONDARY outcome

Timeframe: During each cardiac catheterization, an average of 90 minutes

Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=38 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=42 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose in Cath Lab Room #5, Cardiac Catheterization	25 microsieverts	15 microsieverts

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.

Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Secondary Operator, EP Procedure (RaySafe)	5 microsieverts Interval 3.0 to 16.0	3 microsieverts Interval 1.5 to 5.0

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Secondary Operator, EP Procedure (Luxel)	9 microsieverts	1.6 microsieverts

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.

Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)	2 microsieverts Interval 0.0 to 10.0	0 microsieverts Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)	3.8 microsieverts	0 microsieverts

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 30-45 minutes of active radiation

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.

Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy\*m\^2)

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose to Patient, EP Procedure	72.5 μGy*m^2 Interval 22.7 to 131.5	43.7 μGy*m^2 Interval 26.0 to 95.9

SECONDARY outcome

Timeframe: During each EP implant procedure, an average of 90 minutes

Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.

Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.

Outcome measures

Outcome measures
Measure	Without ControlRad System n=47 Participants Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.	ControlRad System n=43 Participants Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Radiation Dose in Cath Lab Room #5, EP Procedure	0 microsieverts	0 microsieverts

Adverse Events

ControlRad System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Without ControlRad System

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ControlRad System n=85 participants at risk Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.	Without ControlRad System n=85 participants at risk Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
Injury, poisoning and procedural complications Cardiac Perforation	0.00% 0/85 • During each cardiac catheterization/EP procedure, an average of 90 minutes	1.2% 1/85 • Number of events 1 • During each cardiac catheterization/EP procedure, an average of 90 minutes

Other adverse events

Adverse event data not reported

Additional Information

Dr. Simon Dixon, MD

William Beaumont Hospitals

Phone: 248-898-4198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place