Trial Outcomes & Findings for Dosimeter Location in Pain Physicians (NCT NCT06309407)

Results Overview

Dose equivalent in mREM for each dosimeter that is worn by the subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2024-08-13

Participant Flow

All enrolled participants were randomized. There were no participants excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	Chest and Hand Dosimeters Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants	Chest Dosimeter Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
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	Chest and Hand Dosimeters n=5 Participants Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants	Chest Dosimeter n=5 Participants Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=5 Participants	3 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=5 Participants	7 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 months

Population: In the chest and hand dosimeter group, for each participant one chest and one hand dosimeter recording was analyzed. In the chest group, one chest dosimeter recordings was analyzed.

Dose equivalent in mREM for each dosimeter that is worn by the subject.

Outcome measures

Outcome measures
Measure	Chest and Hand Dosimeters n=10 Dosimeters Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants	Chest Dosimeter n=5 Dosimeters Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters
Radiation Readings Chest Dosimeters	122.8 mREM Interval 62.4 to 183.2	158.8 mREM Interval 40.5 to 277.1
Radiation Readings Hand Dosimeters	236.9 mREM Interval 80.7 to 393.3	—

SECONDARY outcome

Timeframe: 6 months

Number of intra-procedure glove breaches

Outcome measures

Outcome measures
Measure	Chest and Hand Dosimeters n=5 Participants Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants	Chest Dosimeter n=5 Participants Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters
Total Number of Glove Breach Events	0 Number of Glove Breach Events	0 Number of Glove Breach Events

Adverse Events

Chest and Hand Dosimeters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chest Dosimeter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sandy Christiansen

Oregon Health and Science University

Phone: 2038092318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place