Trial Outcomes & Findings for Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy (NCT NCT00381966)

Results Overview

Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

at time of intervention

Results posted on

2019-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic Placement Device The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy. robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	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	Robotic Placement Device n=5 Participants The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy. robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of intervention

Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.

Outcome measures

Outcome measures
Measure	Robotic Placement Device n=5 Participants The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy. robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements	0.489 millimeters Standard Deviation 0.328

PRIMARY outcome

Timeframe: at time of intervention

Utility was demonstrated in terms of fine adjustments (≤ 2 mm) and adjustments \>2mm in needle positioning, being possible when tissue deflection was encountered.

Outcome measures

Outcome measures
Measure	Robotic Placement Device n=54 Number of Adjustments The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy. robotic placement device: this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted Adjustments ≤ 2 mm	18 Number of Adjustments
Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted Adjustments > 2 mm	36 Number of Adjustments

Adverse Events

Robotic Placement Device

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

Daniel Song

Johns Hopkins University

Phone: 401-502-5875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place