Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402773
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
Sponsor:
Signati Medical Inc
Organization:
Signati Medical Inc
Study Overview
Official Title:
A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired such as the vas deferens This study will evaluate the Signati SeparoTM System as a vasectomy device
Detailed Description:
This study is designed to be a prospective non-randomized safety study of eight subjects treated at up to three clinical sites in the United States
The primary objective of this study will be to evaluate procedural and post treatment safety and effectiveness of the Signati SeparoTM System treatment via the incidence of adverse events and evaluation of semen post-procedure
This group of subjects will continue to be followed for safety and efficacy for 6 months
The primary objective of this study will be to evaluate procedural and post treatment safety and effectiveness of the Signati SeparoTM System treatment via the incidence of adverse events and evaluation of semen post-procedure
This group of subjects will continue to be followed for safety and efficacy for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None