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NCT03884231 · ClinicalTrials.gov registry record

A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

A clinical trial, sponsored by Abbott Medical Devices.

Completed
Registry status
74
Enrollment target

NCT03884231 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 74 participants.

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The verdict

NCT03884231 has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
74 participants
Enrollment target

Study Summary

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

Interventions

  • DEVICE Infinity DBS System with MR Conditional labelling

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2019-04-10
Est. Completion 2021-08-20

Sponsor

Abbott Medical Devices

261 total trials

What the Registry Record Tells You About NCT03884231

The ClinicalTrials.gov registry entry for NCT03884231 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Infinity DBS System with MR Conditional labelling is the first listed.

NCT03884231 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03884231 about?

NCT03884231 is a clinical study titled "A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling". The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the appro...

What is the current status of trial NCT03884231?

This trial is currently completed. The enrollment target is 74 participants. The study started on 2019-04-10. Estimated completion is 2021-08-20.

What interventions are being tested in trial NCT03884231?

The interventions under investigation include: Infinity DBS System with MR Conditional labelling (DEVICE).

Who is sponsoring clinical trial NCT03884231?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.