Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
SCS Clinical Trial
Official title: Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
Clinical Trial Summary
The objective is to provide information to help the physician community decide the most
effective type of device/therapy that would work for their patients, based off of the
etiology of pain, the location of the pain for sustained pain relief.
Clinical Trial Description
This registry will enroll patients that qualify for an SCS implant, for approved pain areas,
as defined by medicare guidelines, and follow these patients for up to 12 months for denovo
implants. For patients who have lost their pain relief over time, with a prior implanted
device, this registry will follow a change out to another vendor/therapy, and follow those
patients for up to 12 months.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.