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Purpose

The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals aged 18 years and older 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vibrant Capsule
  • Device: Vibrant Capsule
    The Vibrant capsule is designed to alleviate chronic constipation by stimulating the colon through gentle vibrations. The Vibrant capsule will be swallowed and tracked through the digestive system of spinal cord injury patients.

Recruiting Locations

TIRR Memorial Hermann
Houston 4699066, Texas 4736286 77030
Contact:
Jacqueline B Martinez, BS
713-797-5765
Jacqueline.b.martinez@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Argyrios Stampas, MD
7127975938
argyrios.stampas@uth.tmc.edu

Detailed Description

The purpose of this study is to see how well the Vibrant capsule works at treating people with spinal cord injury (SCI)-induced upper motor neuron (UMN) neurogenic bowel. This study will test the safety of the Vibrant capsule. This Vibrant capsule has been approved by the Food and Drug Administration (FDA) for chronic idiopathic constipation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.