RecruitingNot Applicable

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

United States2,000 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 range18 Years

SexALL

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

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

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 range18 Years

SexALL

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

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