Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
NCT ID: NCT07213986
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2026-01-06
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vibrant Capsule
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Mission Connect
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Argyrios Stampas, MD
Professor
Principal Investigators
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Argyrios Stampas, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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TIRR Memorial Hermann
Houston, Texas, United States
Countries
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Central Contacts
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Danira Garcia Gutierrez, BS
Role: CONTACT
Facility Contacts
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References
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American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100 Suppl 1:S1-4. doi: 10.1111/j.1572-0241.2005.50613_1.x. No abstract available.
Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.
Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
Qi Z, Middleton JW, Malcolm A. Bowel Dysfunction in Spinal Cord Injury. Curr Gastroenterol Rep. 2018 Aug 29;20(10):47. doi: 10.1007/s11894-018-0655-4.
Other Identifiers
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Project# 0019646
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC-MS-25-0364
Identifier Type: -
Identifier Source: org_study_id
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