N/A N=87

ReActiv8 Post Market Surveillance Registry

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT03255200 ↗

Enrolled (actual)

Serious AEs

24.1%

Results posted

Oct 2024

Primary outcome: Primary: Low Back Pain - Numeric Pain Rating (NRS) Scale — 4.5; 4.3; 3.8; 3.4 units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: ReActiv8 Implantable Stimulation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mainstay Medical
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Low Back Pain - Numeric Pain Rating (NRS) Scale	4.5; 4.3; 3.8; 3.4	—
SECONDARY Serious Adverse Device Effects	—	—

Summary

To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.

Eligibility Criteria

Inclusion Criteria

Meet the Indications for ReActiv8
Willing to sign the Informed Consent for the Registry
Age ≥ 18 years

Exclusion Criteria

Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03255200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.