RecruitingNot Applicable

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

United States, Australia, Belgium2,000 participantsStarted 2019-03-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must provide written informed consent prior to any clinical investigation related procedure.
. 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.
. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion criteria

. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
. 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.
. Subject has or is scheduled to receive an intrathecal pump.
. Subject is part of a vulnerable population.
. Subject has an existing implanted neuromodulation device to address their chronic pain.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: Baseline

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: Permanent Implant Procedure

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 6 months

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 9 months

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 1 Year

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 1.5 Years

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 2 Years

Trial details

NCT IDNCT03876054

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-06

Contact for this trial

Bram Blomme

+32 474 74 83 10 bram.blomme@abbott.com

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must provide written informed consent prior to any clinical investigation related procedure.
. 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.
. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion criteria

. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
. 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.
. Subject has or is scheduled to receive an intrathecal pump.
. Subject is part of a vulnerable population.
. Subject has an existing implanted neuromodulation device to address their chronic pain.

What they're measuring

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: Baseline

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: Permanent Implant Procedure

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 6 months

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 9 months

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 1 Year

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 1.5 Years

Rate of device and procedure related adverse events, deaths, and device deficiencies

Timeframe: 2 Years