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Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study

NCT05638906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-03-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sanoculis Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-11-28
Completion
2023-12-04

Countries

  • Armenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638906 on ClinicalTrials.gov