Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05638906
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-11-27
Brief Title:
Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study
Sponsor:
Sanoculis Ltd
Organization:
Sanoculis Ltd
Study Overview
Official Title:
Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Schlemms canal SC by removing segments of the trabecular meshwork TM ie 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 ie 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
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 Schlemms canal SC by removing segments of the trabecular meshwork TM ie 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None