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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COMPLETED
43 participants
OBSERVATIONAL
2014-03-06
2015-12-03
Brief Summary
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Detailed Description
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In part one, patients had similar GI Symptoms regardless of baseline gastric emptying or diabetic/non-diabetic status and all patients demonstrated abnormalities in each of the 5 areas studied.
In part two, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diabetic Gastroparesis
Gastric Electrical Stimulation
Temporary and permanent gastric electrical stimulation
Idiopathic Gastroparesis
Gastric Electrical Stimulation
Temporary and permanent gastric electrical stimulation
Interventions
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Gastric Electrical Stimulation
Temporary and permanent gastric electrical stimulation
Eligibility Criteria
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Inclusion Criteria
2. Age 18 or older.
3. Symptoms of gastroparesis for at least 6 months.
4. Refractory or intolerant to antiemetic drugs.
5. Refractory or intolerant to prokinetic drugs.
6. If Diabetic, documentation of medication for diabetes for at least 6 months.
7. No evidence of anatomic obstruction of GI tract. -
Exclusion Criteria
2. History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
3. No know collagen vascular disease.
4. Inability or unwillingness to participate in the study.
5. Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
6. Pregnancy.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Louisville
OTHER
Responsible Party
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Thomas Abell
Professor
References
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Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Gobejishvili L, Omer E, Miller E, Griswold M, Pinkston C. Pathophysiology of Gastroparesis Syndromes Includes Anatomic and Physiologic Abnormalities. Dig Dis Sci. 2021 Apr;66(4):1127-1141. doi: 10.1007/s10620-020-06259-6. Epub 2020 Apr 23.
Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Omer E, Miller E, Griswold M, Pinkston C. Gastroparesis syndromes: Response to electrical stimulation. Neurogastroenterol Motil. 2019 Mar;31(3):e13534. doi: 10.1111/nmo.13534. Epub 2019 Jan 31.
Other Identifiers
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13.0890
Identifier Type: -
Identifier Source: org_study_id
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