Trial Outcomes & Findings for Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies (NCT NCT02120625)

NCT ID: NCT02120625

Last Updated: 2017-04-28

Results Overview

Documentation of Magnetic Resonance Imaging (MRI) evidence of tissue ablation/edema at targeted lumbar medial branches as they course around the superior articular process and transverse process juncture of the vertebrae

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

7 days

Results posted on

2017-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lumbar MB RFN Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lumbar MB RFN Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
Overall Study Physician Decision	2

Baseline Characteristics

Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Demographics n=6 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	6 participants n=93 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production. EMG of lumbar multifidi for medial branch lesion documentation was carried out and percent of successful lesions recorded and analyzed.

Outcome measures

Outcome measures
Measure	Lumbar MB RFN n=6 Participants Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches	100 percentage of participants

PRIMARY outcome

Timeframe: 7 days

Volume of lesions were recorded by the reading radiologists, including proximity to medial branches

Outcome measures

Outcome measures
Measure	Lumbar MB RFN n=6 Participants Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
Volume of Lesions Were Recorded by the Reading Radiologists	602 cubic millimeters Interval 523.0 to 681.0

PRIMARY outcome

Timeframe: 3-6 weeks post radiofrequency ablation

EMG evidence of lesion of the targeted medial branches (Percentage of positive lesions)

Outcome measures

Outcome measures
Measure	Lumbar MB RFN n=34 Lesions Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
EMG Evidence of Lesion of the Targeted Medial Branches	88 percentage of lesions Interval 77.0 to 99.0

SECONDARY outcome

Timeframe: Up to 6 weeks

Outcome measures

Outcome measures
Measure	Lumbar MB RFN n=6 Participants Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
Number of Participants With Serious and Non-Serious Adverse Events	0 Participants

Adverse Events

Lumbar MB RFN

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

J. Scott Bainbridge, MD (PI)

Nimbus Concepts, LLC

Phone: 303-522-5219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has final say on publication of data, after their review. Abstract of data from first 6 cases published: Bainbridge JS, et al; Pain Medicine 2015, Volume 16, Number 8, p.1650
Publication restrictions are in place

Restriction type: OTHER