Intraosseous Basivertebral Nerve Ablation for the Treatme... | NCT03630133

Studies
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

NCT03630133

Sponsor

Relievant Medsystems, Inc.

Status

Withdrawn

Last Update Posted

Jun 17, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

Intracept System Ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Combined with NCT03266107

Expanded Access Info

Start Date

May 8, 2018Actual

Primary Completion Date

Feb 29, 2020Actual

Completion Date

Feb 29, 2020Actual

First Submitted Date

Aug 9, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

Detailed Description

This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intracept System Ablation	Experimental	Single Arm	Device: Intracept System Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intracept System Ablation	Device	Radiofrequency ablation using Intracept System	Intracept System Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oswestry Disability Index (ODI)	Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Visual Analog Scale (VAS)	Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.	3, 6, 9, and 12 months
Oswestry Disability Index (ODI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Skeletally mature subjects age 25-70 years, inclusive
Chronic lower back pain for at least six months
Failure to respond to at least six months of non-operative conservative management
Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

Radicular pain by history or evidence of pain neurological deficit within the past one year.
Previous surgery performed on the lumbar spine
Current or history of symptomatic spinal stenosis
Current or history of osteoporotic or tumor-related vertebral body compression fracture
Current or history of vertebral cancer or spinal metastasis
Current or history of spinal infection
Metabolic bone disease
BMI greater or equal to 40
Any radiographic evidence of other important back pathology
MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
Subjects who are bed bound
Demonstrates 3 or more Waddell's signs of Inorganic Behavior
Any evidence of current systemic infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kevin Macadaeg, MD	Indiana Spine Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Indiana Spine Group		Carmel	Indiana	46032	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

At the completion of trial

Access Criteria

Not provided

URL

http://clbpstudy.com