Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT04726904
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
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:
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
Detailed Description:
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.
However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.
The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.
However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.
In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.
The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.
Study Oversight
Has Oversight DMC:
False
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?: