Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335361
Status:
UNKNOWN
Last Update Posted:
2007-04-06
First Post:
2006-06-07
Brief Title:
Implantable Device for Male Reproductive Sterilization
Sponsor:
Shepherd Medical Company
Organization:
Shepherd Medical Company
Study Overview
Official Title:
The Intra Vas Device IVD As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm
Ninety subjects from two centers in the United Stated will be followed closely for 24 months
If you are someone interested in a vasectomy you may be eligible to participate in this clinical study
Ninety subjects from two centers in the United Stated will be followed closely for 24 months
If you are someone interested in a vasectomy you may be eligible to participate in this clinical study
Detailed Description:
This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device IVD necessary to support the design of a future pivotal study The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH grant R44HD046318 | None | None | None |