Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe University of Texas Health Science Center, Houston
About this trial
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vibrant Capsule
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
Mission Connect
Collaborator
Source ClinicalTrials.gov