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Transdermal Administration by a Novel Wireless Iontophoresis Device
NCT06351852 · View on ClinicalTrials.gov ↗
Study Summary
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially
Conditions Studied
Interventions
- DRUG Combination of Neostigmine and Glycopyrrolate
- DEVICE I-Box by Dynatronics
Study Locations (1)
New York
- James J. Peters Veterans Affairs Medical Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2024-09-24 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06351852
The ClinicalTrials.gov registry entry for NCT06351852 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions — of which Combination of Neostigmine and Glycopyrrolate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06351852 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06351852 about?
NCT06351852 is a clinical study titled "Transdermal Administration by a Novel Wireless Iontophoresis Device". Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in pers...
What is the current status of trial NCT06351852?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2022-03-22. Estimated completion is 2024-09-24.
What conditions does trial NCT06351852 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Constipation, Fecal Incontinence, Neurogenic Bowel. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06351852?
The interventions under investigation include: Combination of Neostigmine and Glycopyrrolate (DRUG), I-Box by Dynatronics (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06351852?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06351852 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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