Ignite Creation Date:
2024-05-06 @ 12:47 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03842410
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2019-02-07
Brief Title:
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique DISST as an Office-based Procedure
Sponsor:
Michigan Institution of Womens Health PC
Organization:
Michigan Institution of Womens Health PC
Study Overview
Official Title:
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique DISST as an Office-based Procedure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique DISSTTM Study endpoints will be feasibility composite success complications and patient and physician acceptance
Detailed Description:
The single-incision midurethral sling SIMUS is a procedure where there are no exit incisions There is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle on each side This procedure has potentially lesser side-effects compared to the longer slings however the literature has not found the SIMUS to be as effective as the long slings In our recently published study the DISSTTM technique has significantly improved the success of the SIMUS procedure as the sling can be tested for proper application in vivo
As we have performed several of these procedures in the operating room entirely under local anesthesia we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room
Performing this procedure in the office has significant benefits for the patient the healthcare industry and the economy overall Moving away from a hospital setting has significant psychological benefits This will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment
It would also eliminate the risk of nosocomial infections for the patient and family members improve efficiency as the wait time would be negligible and would reduce the expense of the entire treatment as hospital costs would not feature in the equation
This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique DISSTTM Study endpoints will be feasibility composite success complications and patient and physician acceptance
As we have performed several of these procedures in the operating room entirely under local anesthesia we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room
Performing this procedure in the office has significant benefits for the patient the healthcare industry and the economy overall Moving away from a hospital setting has significant psychological benefits This will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment
It would also eliminate the risk of nosocomial infections for the patient and family members improve efficiency as the wait time would be negligible and would reduce the expense of the entire treatment as hospital costs would not feature in the equation
This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique DISSTTM Study endpoints will be feasibility composite success complications and patient and physician acceptance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None