Chronic PainREALITYNCT03876054
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
An observational study of Chronic Pain, run by Abbott Medical Devices at 55 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Spinal cord stimulation (SCS) and Dorsal root ganglion stimulation (DRG)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 55 sitesin 9 countries
- Study dates
- 13 Mar 2019to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
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 (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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 9 countries
United States30 sites
- Terminated
Premier Pain Solutions
Asheville, North Carolina, 28803
- Active, not recruiting
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, 25301
- Terminated
Saint Louis Pain Consultants
Chesterfield, Missouri, 63017
- Active, not recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Active, not recruiting
University of Chicago
Chicago, Illinois, 60637
- Withdrawn
Adena Bone and Joint Center
Chillicothe, Ohio, 45601
- Active, not recruiting
Nura
Edina, Minnesota, 55435
- Terminated
Twin Cities Pain Clinic
Edina, Minnesota, 55439
- Active, not recruiting
Pacific Sports & Spine
Eugene, Oregon, 97401
- Active, not recruiting
Center for Interventional Pain & Spine
Exton, Pennsylvania, 19341
- Terminated
University of Florida Department of Anesthesia
Gainesville, Florida, 32610
- Terminated
Advanced Pain Care
Henderson, Nevada, 89052
- Active, not recruiting
Expert Pain
Houston, Texas, 77079
- Active, not recruiting
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46032
- Terminated
Central Texas Pain Institute
Killeen, Texas, 76542
- Terminated
Integrated Pain Associates
Killeen, Texas, 76542
- Terminated
California Orthopedics & Spine
Larkspur, California, 94939
- Withdrawn
Premier Pain Treatment Institute
Loveland, Ohio, 45140
- Terminated
Ainsworth Institute of Pain Management
New York, New York, 10022
- Terminated
Restore Orthopedics & Spine Center
Orange, California, 92868
- Terminated
Phoenician Centers for Research & Innovation
Phoenix, Arizona, 85021
- Terminated
Foothills Pain Management Clinic
Pomona, California, 91767
- Terminated
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
- Active, not recruiting
Unity Spine Center
Rochester, New York, 14626
- Terminated
Advanced Pain Care
Round Rock, Texas, 78664
- Terminated
Pacific Research Institute
Santa Rosa, California, 95403
- Active, not recruiting
The Spine & Pain Institute of New York
Staten Island, New York, 10305
- Terminated
Spinal Diagnostics
Tualatin, Oregon, 97062
- Terminated
Pain Institute of Southern Arizona
Tucson, Arizona, 85718
Germany9 sites, 1 recruiting
- Recruiting
Krankenhaus Porz am Rhein
Cologne, Koln, 51149
Thomas May
- Terminated
Kliniken der Stadt Köln-Merheim
Cologne, North Rhine-Westphalia, 51109
- Terminated
Klinikum Duisburg GmbH
Duisburg, N. RHIN, 47055
- Active, not recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, N. RHIN, 40225
- Terminated
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
Gera, Thuringia, 07548
- Active, not recruiting
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria, 85049
- Terminated
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
- Terminated
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN, 41066
- Terminated
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, 72076
United Kingdom4 sites
- Terminated
Southmead Hospital
Bristol, Sowest, BS10 5NB
- Terminated
Seacroft Hospital
Leeds, Yorkshire and the Humber, LS14 6UH
- Terminated
The Walton Centre
Liverpool, North West England, L9 7LJ
- Terminated
Norfolk and Norwich Hospital
Norwich, England, NR4 7UY
Spain3 sites
- Terminated
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
- Terminated
Hospital Universitario de Salamanca
Salamanca, Cstleon, 37007
- Terminated
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
Australia2 sites
- Terminated
Metro Pain Group
Clayton, Victoria, 3168
- Terminated
Precision Brain, Spine & Pain Centre
Kew, Victoria, 3101
Belgium2 sites
- Terminated
AZ Delta vzw
Roeselare, West Flanders, 8800
- Terminated
AZ Nikolaas
Sint-Niklaas, Eflndrs, 9100
Italy2 sites
- Active, not recruiting
Azienda Ospedaliera Monaldi
Naples, Campani, 80131
- Active, not recruiting
Fondazione Salvatore Maugeri
Pavia, Lombard, 27100
Netherlands2 sites
- Terminated
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
- Active, not recruiting
Erasmus MC
Rotterdam, S Holln, 3015
Switzerland1 site
- Active, not recruiting
Hôpital du Valais
Sion, Valais, 1951
About this study
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.
Read the detailed description
This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.
- Conditions
- Chronic Pain
- Being tested
- Spinal cord stimulation (SCS), Dorsal root ganglion stimulation (DRG)
- Keywords
- spinal cord stimulation, dorsal root ganglion stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation (SCS)Device
Subjects will be implanted with market-released Abbott SCS systems
Dorsal root ganglion stimulation (DRG)Device
Subjects will be implanted with market-released Abbott DRG system
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation (SCS) | Subjects using Abbott SCS systems Receives: Device: Spinal cord stimulation (SCS) | |
| Dorsal root ganglion stimulation (DRG) | Subjects using Abbott DRG system Receives: Device: Dorsal root ganglion stimulation (DRG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: Baseline
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: Permanent Implant Procedure
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 6 months
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 9 months
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 1 Year
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 1.5 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 2 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 2.5 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 3 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 3.5 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 4 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 4.5 Years
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start13 Mar 2019
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Devyani Nanduri, Study director, Abbott Medical Devices Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876054
- Sponsor's protocol ID
- ABT-CIP-10279
- Acronym
- REALITY
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
- ClinicalTrials.gov ID
- NCT03876054
- Acronym / sponsor ID
- REALITY / ABT-CIP-10279
- Conditions
- Chronic Pain
- Keywords
- spinal cord stimulation, dorsal root ganglion stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Mar 2019 (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.
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.
Detailed description
This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation (SCS) | – | Device: Spinal cord stimulation (SCS)Subjects using Abbott SCS systems |
| Dorsal root ganglion stimulation (DRG) | – | Device: Dorsal root ganglion stimulation (DRG)Subjects using Abbott DRG system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Spinal cord stimulation (SCS)Subjects will be implanted with market-released Abbott SCS systems | Device | Spinal cord stimulation (SCS) |
| Dorsal root ganglion stimulation (DRG)Subjects will be implanted with market-released Abbott DRG system | Device | Dorsal root ganglion stimulation (DRG) |
Primary outcome
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: Baseline
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: Permanent Implant Procedure
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 6 months
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 9 months
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 1 Year
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 1.5 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 2 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 2.5 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 3 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 3.5 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 4 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 4.5 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Rate of device and procedure related adverse events, deaths, and device deficiencies
Time frame: 5 Years
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
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.
Devyani Nanduri study director
Abbott Medical Devices Neuromodulation
55 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Abbott Medical Devices at 55 sites in 9 countries.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Germany, United Kingdom, Spain, Australia and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bram Blomme (+32 474 74 83 10, bram.blomme@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device and procedure related adverse events, deaths, and device deficiencies (time frame: Baseline). The study lists 13 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 7 Jan 2026.