NCT05638906

Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sanoculis Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Minimally Invasive Nasal Trabeculostomy System is intended for the reduction of elevated Intraocular Pressure (IOP). The system is a powered surgical device, designed to create trabeculostomy openings of \~100 microns diameter each, via an ab-interno approach, directly from the anterior chamber (AC) into Schlemm's canal (SC) by removing segments of the trabecular meshwork (TM) (i.e., an ab-interno nasal trabeculostomy). The ab-interno approach aims to decrease IOP by increasing aqueous outflow through a direct communication from the AC to the outer wall of SC and the collector channels. The opening in the nasal TM to the SC is created by a sterile surgical instrument (the Surgical Device) made of stainless steel and plastic, which is coupled to a rotating system (the Activation Device). The Surgical Device of the Minimally Invasive Nasal Trabeculostomy System consists of a stainless steel micro trephine, covered by a small needle-shaped sleeve with a rotating mechanism behind it. While being rotated, the Surgical Device enters and moves along the TM, removing TM tissue with minimal collateral damage. Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.

Conditions

• This Study is Obtained Under Inclusion/ Exclusion Criteria

Interventions

Type	Name	Description
DEVICE	MINT	Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-11-28
• Completion: 2023-12-04
• First posted: 2022-12-06
• Last updated: 2024-03-12

Locations

1 site across 1 country: Armenia