NCT03794661

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Essential Tremor
• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	Clinician programmer electrode screening mode tool	Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process

Timeline

• Start date: 2019-06-26
• Primary completion: 2020-12-16
• Completion: 2020-12-16
• First posted: 2019-01-07
• Last updated: 2022-03-31
• Results posted: 2022-03-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study