NCT04981470

The Baroloop Study

A First in Human Study of Feasibility of Baroloop: The Baroloop Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: neuroloop GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The baroloop Study is a non-randomized, prospective, single-arm, multi center First in Human (FIH) study with the primary objective being the assessment of the safety and feasibility of using the baroloop System in subjects with uncontrollable hypertension. The secondary objective is to document the effect of the baroloop device on the blood pressure and quality of life in subjects with hypertension. Up to 10 subjects will be enrolled in up to 3 sites in Europe.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	baroloop System	vagal nerve stimulation

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2021-07-29
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: Netherlands