Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177340
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-12-11
Brief Title:
Nanoscope System During Sacrospinofixation
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Visualization by the Nanoscope System During Sacrospinofixation
Status:
RECRUITING
Status Verified Date:
2024-02
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:
SF-CAM
Brief Summary:
Sacrospinofixation is one of the reference techniques for the treatment of vaginal prolapse It consists of fixing a non-absorbable thread on the sacrosciatic ligament unilaterally or bilaterally to correct a urogenital prolapse
The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control However if the thread is not well fixed in the ligament there is a risk of this suture coming loose and therefore of recurrence of the prolapse On the other hand due to the vascular and nervous proximity pudendal nerve vascular complications such as hemorrhage andor hematoma have been described by vascular lesion during the passage of the needle through this ligament Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described which can cause after-effects of pain or even chronic dyspareunia
Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences but also to avoid these serious and disabling complications
The Nanoscope system which can be used in routine practice as part of sacrospinofixation could make it possible to obtain visibility of tissues under vision control Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures
The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control However if the thread is not well fixed in the ligament there is a risk of this suture coming loose and therefore of recurrence of the prolapse On the other hand due to the vascular and nervous proximity pudendal nerve vascular complications such as hemorrhage andor hematoma have been described by vascular lesion during the passage of the needle through this ligament Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described which can cause after-effects of pain or even chronic dyspareunia
Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences but also to avoid these serious and disabling complications
The Nanoscope system which can be used in routine practice as part of sacrospinofixation could make it possible to obtain visibility of tissues under vision control Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures
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