N/A
ID
Bron
Aandoening
Chronic Neuropathic Pain
Ondersteuning
1135 O'Brien Dr.
Menlo Park, CA 94025
USA
1135 O'Brien Dr.
Menlo Park, CA 94025
USA
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Device Safety as determined by adverse event reporting. Adverse event profiles are expected to be similar to currently approved devices. These can include infection, lead migration, etc;<br>
2. Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksopzet
Multiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.
Onderzoeksproduct en/of interventie
This intervention involves the placement of epidural leads that provide stimulation. Stimulation intensity and the amount of of stimulation during the day is controlled by the subject to the desired levels during the duration of the clinical trial. The mechanism of action is unknown. Subjects will be followed up for 12 months following implantation neurostimulator system. Trial duration is expected to be approximately 15-18 months.
Algemeen / deelnemers
1135 O'Brien Dr.
Jeffery Kramer
Menlo Park CA 94025
USA
+1 650 543 6800
jeff@spinalmodulation.com
Wetenschappers
1135 O'Brien Dr.
Jeffery Kramer
Menlo Park CA 94025
USA
+1 650 543 6800
jeff@spinalmodulation.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Male or female ≥ 18 years old;
2. Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months;
3. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain;
4. Minimum baseline pain rating of 60 mm on the VAS;
5. Stable pain medication dosage for at least 30 days;
6. Stable neurologic function in the past 30 days.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control;
2. Escalating or changing pain condition within the past month as evidenced by investigator examination;
3. Subject is currently involved in medically related litigation;
4. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump;
5. Subject currently has an active infection;
6. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device;
7. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation;
8. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2695 |
NTR-old | NTR2825 |
Ander register | Spinal Modulation, Inc. : 01-SMI-2010 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |