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

Failed Back Surgery Syndrome Clinical Trial

Official title:

A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02634398
• Other study ID #: 26-SMI-2015
• Status: Withdrawn
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Locations

Country	Name	City	State
Switzerland	Centre d'Antalgie de l'EHC-Hôpital de Morges	Morges	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief	Assessed by change in pain intensity on a Visual Analogue Scale (VAS) from pre-treatment baseline	Post implantation at; 1 week and 1, 3, 6 and 12 months