NCT05537662 · Abbott Medical Devices
External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
(XANADO)
What this study is about
This is a forward-looking, longitudinal, single-center, non-randomly assigned, where both patients and doctors know the treatment given, post-market clinical feasibility study to assess the effectiveness of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
View original scientific description
This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years of age or older at the time of enrollment.
- Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
- Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment and commencement of the baseline data collection period.
- Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
- Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
- Subject is willing to cooperate with the study requirements including completion of all office visits.
- Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre).
- Subject agrees to answer questionnaires regularly for the duration of the study.
Exclusion criteria
- Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Subject is part of a vulnerable population.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
- Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
- Subject has already participated in a SCS trial period before enrolling in the study.
- Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
- Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
- Subject has tremors (e.g. Parkinson's disease or Familial tremors).
- Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
- Subject is bedridden.
Where
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 12, 2024 · Source of record for eligibility and locations