Nanoscope System During Sacrospinofixation (SF-CAM)

Visualization by the Nanoscope System During Sacrospinofixation

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.

Study Overview

• Status: Recruiting
• Conditions: Sacrospinofixation
• Intervention / Treatment: Device: visualization of the sacrospinous ligament

• Study Type: Observational
• Enrollment (Estimated): 5

Contacts and Locations

• Study Contact: Name: Gautier CHENE, MD, PhD; Phone Number: +33 (4) 72 35 58 70; Email: gautier.chene@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69500
    • Recruiting
    • Hopital Femme Mere Enfant
    • Contact: Gautier CHENE, MD, PhD; Phone Number: +33 (4) 72 35 58 70; Email: gautier.chene@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This study concerns patients who underwent anterior and/or posterior sacrospinofixation surgery to correct a prolapse and for whom the Nanoscope system was used.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sacrospinofixation; patient who benefited from anterior and/or posterior sacrospinofixation using the Nanoscope system	Device: visualization of the sacrospinous ligament; visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visualization of the sacrospinous ligament	Obtaining visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation (binary criterion: yes/no)	during surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nanoscope system; sacrospinofixation
• Other Study ID Numbers: 23-5408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No