NCT05795829

Ultrasound Ablation for Essential Hypertension（FIM）

First in Man Study to Evaluate the Safety and Efficacy of Disposable Intravascular Ultrasound Ablation Catheters and Ultrasound Ablation Instrument in the Treatment of Essential Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension.

Detailed description

Feasibility Research This is a prospective, small-sample, single-group study. A total of 10 subjects are planned to be included in this study. Disposable intravascular catheter and instrument are used for intravascular ultrasound ablation. All participants will be followed up by telephone or outpatient at 1, 2 and 6 months post-procedure, with procedural success rate as the primary endpoint. At the same time, the incidence of adverse events will be observed to make a preliminary evaluation of the safety and feasibility of disposable intravascular catheter and instrument, and to provide data support for the second-stage confirmatory study. In feasibility research, statistical analysis of data will be performed after 30 days postoperative follow-up of the subjects, and the safety and feasibility of disposable intravascular catheter and instrument will be preliminarily evaluated before entering the stage of confirmatory trial.

Conditions

• Uncontrolled Essential Hypertension

Interventions

Type	Name	Description
DEVICE	disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument	Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries.

Timeline

• Start date: 2023-01-16
• Primary completion: 2023-12-31
• Completion: 2024-02-29
• First posted: 2023-04-03
• Last updated: 2023-04-03

Locations

2 sites across 1 country: China