Chronic PainXANADONCT05537662
External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
A study of Chronic Pain, run by Abbott Medical Devices at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Daniel Torrez, BS, 312-942-2741, daniel_torrez@rush.edu
Tolga Suvar, MD
About this study
Official title: External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes
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.
- Conditions
- Chronic Pain
- Being tested
- Standard of care neuromodulation therapy (SCS or DRG)
- Keywords
- ABT-CIP-10458, Chronic Pain, Neuromodulation System, SCS, Diabetic Pain, DRG
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care neuromodulation therapy (SCS or DRG)Device
Standard SCS or DRG therapy
| Study group | Role | What they receive |
|---|---|---|
| Subjects using Neuromodulation Therapy (SCS or DRG) | Experimental | Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant. Receives: Device: Standard of care neuromodulation therapy (SCS or DRG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months
Change in pain scores measured by the NRS at baseline and follow up study visits at 3 months.
Measured: At 3 month
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months
Change in pain scores measured by the NRS at baseline and follow up study visits at 6 months.
Measured: At 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start6 Jun 2023
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537662
- Sponsor's protocol ID
- ABT-CIP-10458
- Acronym
- XANADO
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes
- ClinicalTrials.gov ID
- NCT05537662
- Acronym / sponsor ID
- XANADO / ABT-CIP-10458
- Conditions
- Chronic Pain
- Keywords
- ABT-CIP-10458, Chronic Pain, Neuromodulation System, SCS, Diabetic Pain, DRG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects using Neuromodulation Therapy (SCS or DRG) | Experimental | Device: Standard of care neuromodulation therapy (SCS or DRG)Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care neuromodulation therapy (SCS or DRG)Standard SCS or DRG therapy | Device | Subjects using Neuromodulation Therapy (SCS or DRG) |
Primary outcome
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months
Time frame: At 3 month
Change in pain scores measured by the NRS at baseline and follow up study visits at 3 months.
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months
Time frame: At 6 month
Change in pain scores measured by the NRS at baseline and follow up study visits at 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Pain, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Blomme (+32 (0)2 774 68 50, bram.blomme@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months (time frame: At 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.