Trial Outcomes & Findings for Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures (NCT NCT01287013)

NCT ID: NCT01287013

Last Updated: 2018-01-05

Results Overview

Comparing the accuracy of the path the biopsy needle took to get to the site

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2018-01-05

Participant Flow

Recruitment period = 2/4/2011 - 5/15/2014 Recruitment location = Interventional Radiology Clinic, Department of Radiology and Imaging Sciences, Clinical Center, NIH

The PILOT Arm of the study was done prior to enrolling participants in the main phase of the study. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. Participants enrolled in the PILOT Arm were not randomized to either the Cone Beam CT or Conventional CT Arms and not included in the analysis.

Participant milestones

Measure	Cone Beam CT Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT Procedure performed with Conventional Computed Tomography (CT) image guidance	PILOT Procedures performed with Xperguide without randomization to familiarize operators.
Overall Study STARTED	32	34	21
Overall Study COMPLETED	29	29	0
Overall Study NOT COMPLETED	3	5	21

Reasons for withdrawal

Measure	Cone Beam CT Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT Procedure performed with Conventional Computed Tomography (CT) image guidance	PILOT Procedures performed with Xperguide without randomization to familiarize operators.
Overall Study Non-evaluable	3	5	21

Baseline Characteristics

Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Baseline characteristics by cohort

Measure	Cone Beam CT n=32 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=34 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance	PILOT n=21 Participants Procedures performed with Xperguide without randomization to familiarize operators.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	8 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	26 Participants n=7 Participants	17 Participants n=5 Participants	57 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.

Outcome measures

Measure	Cone Beam CT n=29 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance
Comparing the Accuracy of Final Device Tip Position	4.9 mm Standard Deviation 4.1	12.2 mm Standard Deviation 8.1

PRIMARY outcome

Timeframe: 1 hour

Population: Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

Comparing the accuracy of the path the biopsy needle took to get to the site

Outcome measures

Measure	Cone Beam CT n=29 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance
Accuracy of Final Device Path (Vector)	8.8 mm Standard Deviation 5.4	28.3 mm Standard Deviation 20.5

PRIMARY outcome

Timeframe: 1 hour

Population: Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

Comparing radiation doses to determine if there is a change in the dose between the two interventions

Outcome measures

Measure	Cone Beam CT n=29 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance
Radiation Doses Between Xperguide and Conventional CT	53.3 mGy Standard Deviation 33.3	75.4 mGy Standard Deviation 62.6

SECONDARY outcome

Timeframe: 1 hour

Population: Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.

Outcome measures

Measure	Cone Beam CT n=29 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance
Compare the Number of Repositioning Maneuvers	0.3 number of repositioning maneuvers Standard Deviation 0.5	1.9 number of repositioning maneuvers Standard Deviation 2.3

SECONDARY outcome

Timeframe: 1 hour

Population: Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.

Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.

Outcome measures

Measure	Cone Beam CT n=29 Participants Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 Participants Procedure performed with Conventional Computed Tomography (CT) image guidance
Rates of Definitive Pathologic Diagnosis	93.9 percent of accuracy	90.9 percent of accuracy

Adverse Events

Cone Beam CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional CT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Pilot Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cone Beam CT n=29 participants at risk Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation	Conventional CT n=29 participants at risk Procedure performed with Conventional Computed Tomography (CT) image guidance	Pilot Arm n=21 participants at risk Pilot participants were enrolled to familiarize operators with performing Xperguide procedures.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/29 • 1 day	3.4% 1/29 • Number of events 1 • 1 day	0.00% 0/21 • 1 day

Other adverse events

Adverse event data not reported

Additional Information

Bradford Wood, MD

National Institutes of Health

Phone: (301) 496-7739

Email: bwood@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place