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WithdrawnNCT02634398Updated Feb 4, 2019

A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)

An observational study in Failed Back Surgery Syndrome, sponsored by Abbott Medical Devices. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices (part of Abbott) · Observational

Why this study was withdrawn
Lack of enrollments
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.

02

Conditions studied

  • Failed Back Surgery Syndrome
03

In context

Failed Back Surgery Syndrome

101 studies on the registry are indexed under Failed Back Surgery Syndrome; 16 are open to participants now.

Browse Failed Back Surgery Syndrome studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffering from chronic pain post discectomy surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is at least 18 years old
  2. Subject is able and willing to comply with the follow-up schedule and protocol
  3. Chronic pain following surgical lumbar discectomy for at least 6 months
  4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
  5. Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain
  6. Subject is able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
  2. Escalating or changing pain condition within the past month as evidenced by investigator examination
  3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
  4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
  6. Subject is unable to operate the device
  7. Subjects with indwelling devices that may pose an increased risk of infection
  8. Subjects currently has an active infection
  9. Subject has participated in another clinical investigation within 30 days
  10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  11. Subject has been diagnosed with cancer in the past 2 years.
  12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Treated subjects

    All subjects recruited and treated wiht the Axium neurostimulator

06

What researchers measure

Primary outcomes

  1. Pain Relief

    Assessed by change in pain intensity on a Visual Analogue Scale (VAS) from pre-treatment baseline

    Time frame: Post implantation at; 1 week and 1, 3, 6 and 12 months

07

Study locations

1 site
  • Centre d'Antalgie de l'EHC-Hôpital de Morges
    Morges, Canton of Vaud 1110, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02634398
Responsible party
Sponsor
First posted
Dec 18, 2015
Start date
Dec 2015
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Feb 4, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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