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Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

NCT05565469 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-04

No results posted yet for this study

Summary

In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients

Conditions

Interventions

OTHER

Adjustment of neurostimulator settings

This is an interventional prospective study. After obtaining informed consent, only necessary information will be extracted through the electronic patient record. Through post-operative imaging, a level determination of the neurostimulator tip will be done. During general consultations, patients will be asked if they experienced abdominal wall stimulation after the procedure and when (YES/NO, NRS). This will include looking at the settings of the neurostimulator. And its adjustments. Furthermore, general epidemiological characteristics such as age, gender, height, weight will be extracted from the electronic patient record. At the consultation, another active programming will take place (in accordance with clinical programming) on the tip of the electrode to check whether it provokes abdominal wall stimulation. This will also be scored YES/NO + NRS. Then the settings will be returned as they were pre-consultation.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Mark Plazier, dr. · Jessa Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2022-12-31
Completion
2023-02-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565469 on ClinicalTrials.gov