Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
United States12 participantsStarted 2026-01-06
Plain-language summary
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Individuals with chronic spinal cord injury (SCI) of more than one year.
* Stable neurological level and function of SCI for at least six months.
* Consistent bowel program without changes for at least 3 months.
* At least one scheduled bowel movement (BM) every three days.
* Use of digital stimulation, suppositories, enemas, or mini enemas, as part of the scheduled bowel program.
* Use of oral medications as part of the bowel program.
Exclusion Criteria:
* Bowel incontinence occurring more than once per week.
* Non-English-speaking individuals.
* History of bowel obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok).
* Persistent autonomic dysreflexia (AD) triggered by bowel movements.
* Recent changes to spasticity medications within the past month.
* History of significant gastrointestinal disorders
* History of Zenker's diverticulum
* Dysphagia
* Esophageal stricture
* Eosinophilic esophagitis or achalasia
* Pregnancy.
* Presence of implanted devices that could be affected by proximity to a direct current magnetic field.
What they're measuring
1
Safety of Vibrant capsule as indicated by number of participants who had an adverse event