Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

NCT ID: NCT03997825

Last Updated: 2021-01-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-13

Study Completion Date

2019-11-08

Brief Summary

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The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.

Detailed Description

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This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.

Conditions

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Chronic Low Back Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Basivertebral Nerve (BVN) Ablation

Single follow-up visit of previously treated participants from the SMART trial.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* LBP at least 6 months from original SMART Trial
* RF Ablation Arm from SMART Trial

Exclusion Criteria

-Control Arm Subjects from SMART Trial
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Relievant Medsystems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Fischgrund, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Desert Institute for Spine Care

Phoenix, Arizona, United States

Site Status

SpineCare Medical Group

Daly City, California, United States

Site Status

Memorial Orthopedic Surgical Group

Long Beach, California, United States

Site Status

Cedars Sinai Spine Center

Los Angeles, California, United States

Site Status

Drug Studies of America

Marietta, Georgia, United States

Site Status

Indiana Spine Group

Carmel, Indiana, United States

Site Status

Maine Medical Partners

Scarborough, Maine, United States

Site Status

Michigan Orthopedics Instititute

Southfield, Michigan, United States

Site Status

OrthoCarolina

Charlotte, North Carolina, United States

Site Status

Pacific Sports and Spine

Eugene, Oregon, United States

Site Status

Rothman Orthopedic Institute

Bensalem, Pennsylvania, United States

Site Status

Seton Spine and Scoliosis Center

Austin, Texas, United States

Site Status

Virginia iSpine Physicians

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CIP 0011

Identifier Type: -

Identifier Source: org_study_id

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