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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06177340
Other study ID # 23-5408
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 10, 2024
Est. completion date April 28, 2024

Study information

Verified date February 2024
Source Hospices Civils de Lyon
Contact Gautier CHENE, MD, PhD
Phone +33 (4) 72 35 58 70
Email gautier.chene@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date April 28, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
visualization of the sacrospinous ligament
visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation

Locations

Country Name City State
France Hôpital Femme Mère Enfant Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary visualization of the sacrospinous ligament Obtaining visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation (binary criterion: yes/no) during surgery
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04551859 - Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery N/A