NCT04071847 Abbott DBS Post-Market Study of Outcomes for Indications Over Time
| NCT ID | NCT04071847 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Movement Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-11-26 |
| Primary Completion | 2029-09 |
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 1,000 participants in total. It began in 2019-11-26 with a primary completion date of 2029-09.
⚠ 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 purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
Eligibility Criteria
Inclusion Criteria: 1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days. 2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure. Exclusion Criteria: 1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study. 2. Subject has 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 study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor. 4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.
Contact & Investigator
Devyani Nanduri
STUDY DIRECTOR
Abbott Medical Devices Neuromodulation
Frequently Asked Questions
Who can join the NCT04071847 clinical trial?
This trial is open to participants of all sexes, studying Movement Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04071847 currently recruiting?
Yes, NCT04071847 is actively recruiting participants. Contact the research team at claudia.salazar4@abbott.com for enrollment information.
Where is the NCT04071847 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Sacramento, United States, Littleton, United States and 11 additional locations.
Who is sponsoring the NCT04071847 clinical trial?
NCT04071847 is sponsored by Abbott Medical Devices. The principal investigator is Devyani Nanduri at Abbott Medical Devices Neuromodulation. The trial plans to enroll 1,000 participants.