NCT07519915 Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables
| NCT ID | NCT07519915 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg |
| Condition | Gastrointestinal Motility Disorders in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2018-07-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
Eligibility Criteria
Inclusion Criteria: * informed consent of patient and care taker * gastrointestinal motility disorder, disregarding underlying diseases * exclusion of mechanical obstructions in the gastrointestinal passage * age between 3 and 18 Exclusion Criteria: * pregnancy/breast feeding * decreased renal or thyroidal function * drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin * contradictions for MRI * indication for analgosedation for MRI * inflammatory bowel diseases * fractures/different anatomy in sacral region * epilepsy * presence of cardiac pacemakers
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07519915 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Gastrointestinal Motility Disorders in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07519915 currently recruiting?
Yes, NCT07519915 is actively recruiting participants. Contact the research team at sonja.diez@uk-erlangen.de for enrollment information.
Where is the NCT07519915 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT07519915 clinical trial?
NCT07519915 is sponsored by Friedrich-Alexander-Universität Erlangen-Nürnberg. The trial plans to enroll 25 participants.