Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-31 @ 1:45 AM
Study NCT ID:
NCT03794661
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIDENT
Brief Summary:
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
Detailed Description:
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: