NCT03876054 Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
| NCT ID | NCT03876054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Chronic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2019-03-13 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2019-03-13 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.
Eligibility Criteria
Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation related procedure. 2. Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment. 3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline. 4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6. Exclusion Criteria: 1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott. 2. 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. 3. Subject has or is scheduled to receive an intrathecal pump. 4. Subject is part of a vulnerable population. 5. Subject has an existing implanted neuromodulation device to address their chronic pain.
Contact & Investigator
Devyani Nanduri
STUDY DIRECTOR
Abbott Medical Devices Neuromodulation
Frequently Asked Questions
Who can join the NCT03876054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03876054 currently recruiting?
Yes, NCT03876054 is actively recruiting participants. Contact the research team at bram.blomme@abbott.com for enrollment information.
Where is the NCT03876054 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Larkspur, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT03876054 clinical trial?
NCT03876054 is sponsored by Abbott Medical Devices. The principal investigator is Devyani Nanduri at Abbott Medical Devices Neuromodulation. The trial plans to enroll 2,000 participants.
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