Skip to content

Nanoscope System During Sacrospinofixation

Visualization by the Nanoscope System During Sacrospinofixation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06177340
Acronym
SF-CAM
Enrollment
5
Registered
2023-12-20
Start date
2024-01-10
Completion date
2024-04-28
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacrospinofixation

Keywords

Nanoscope system, sacrospinofixation

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 and/or 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.

Interventions

DEVICEvisualization of the sacrospinous ligament

visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years

Inclusion criteria

* women over 18 * patient who benefited from anterior and/or posterior sacrospinofixation using the nanoscope system * person having expressed his non-opposition

Exclusion criteria

* inability to understand the information given * person deprived of liberty * person under guardianship

Design outcomes

Primary

MeasureTime frameDescription
visualization of the sacrospinous ligamentduring surgeryObtaining visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation (binary criterion: yes/no)

Countries

France

Contacts

Primary ContactGautier CHENE, MD, PhD
gautier.chene@chu-lyon.fr+33 (4) 72 35 58 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026