Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve

Study acronym: GES
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 158 participants (planned 300)
    • Primary completion date changed from estimate of Dec 2026 to Sep 16, 2024
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 570 words
  2. Start date: Nov 2012 to Nov 1, 2012v12
  3. Re-verified, no change to tracked fieldsv11
  4. Trial status: Enrolling by Invitation to Active, Not Recruitingv10
  5. Enrollment target: 200 to 300v9 Show 4 more changesShow less
    • Primary completion date: Dec 2020 to Dec 2026
    • Study completion date: Dec 2020 to Dec 2027
    • Secondary endpoints expanded, about 6 words
    • Study description expanded, about 1,113 words
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Collaborators expanded, about 2 wordsv7
  3. Primary and study completion dates: Dec 2017 to Dec 2020v6
  4. Primary and study completion dates: Dec 2016 to Dec 2017
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Eligibility criteria shortened, about 1 word
    • Study description shortened, about 4 words
    v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study is to determine if Gastric Electrical Stimulation may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.
Trial Details
NCT Number NCT02159586
Lead Sponsor Indiana University
Collaborators: Purdue University
Conditions
(from sponsor)		 Gastroparesis
Related terms Gastroparesis, Nausea, Vomiting
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov