Stimwave HF SCS Pilot Study

NCT02787252 | Completed

• 1 other identifier: 30-00178
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.

Conditions

FBSS

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Outcome (VAS)

  The primary outcome is defined as the percentage of subjects who respond (50% average or more pain relief for back and leg pain) to SCS therapy at the end of 12 weeks post-implant of the system as compared to baseline with no increase in medication. The primary outcome will be measured with the VAS (100 mm line).

  12 weeks post-implant

• Primary Safety Outcome (Adverse Events)

  Incidence and severity of device related adverse events during the study

  12 weeks post-implant

Secondary Outcomes (2)

• VAS

  12 weeks post-implant

• ODI

  12 weeks post-implant

Study Arms (1)

HF DRG

EXPERIMENTAL

HF DRG Implants

Device: Implant procedure, Freedom Spinal Cord Stimulation System

Interventions

Implant procedure, Freedom Spinal Cord Stimulation System DEVICE

A needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back.

HF DRG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Subject is ≥ 18 years of age at time of informed consent;
• B. Subjects have been diagnosed with chronic, intractable pain of the trunk and/or lower limbs with a VAS \> 5cm (on a 10-cm scale);
• C. Subject diagnosis with chronic pain refractory to conventional medical management for at least 6 months prior to enrollment;
• D. Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
• E. Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
• F. Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
• G. Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
• H. Subject is male or non-pregnant female;
• I. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of the investigator, using face-to-face encounters and the psychological testing described in the measures;
• J. Patient is capable of giving informed consent;
• K. Patient lives within reasonable distance from the study site (circumference of 75 km).

You may not qualify if:

• A. Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
• B. Malignancies;
• C. Subject has post-herpetic neuralgia (shingles);
• D. Subject has an active systemic infection or is immune-compromised.
• E. Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
• F. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
• G. Insulin-dependent diabetic who is not controlled through diet and/or medication;
• H. Bleeding complications or coagulopathy issues;
• I. Pregnant/lactating or not using adequate birth control;
• J. A life expectancy of less than one year;
• K. Any active implanted device whether turned off or on;

Sponsors & Collaborators

• Curonix LLC: lead

Study Sites (1)

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

BE (1)