Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
NCT ID: NCT06854120
Last Updated: 2025-03-03
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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NOT_YET_RECRUITING
125 participants
OBSERVATIONAL
2025-02-26
2028-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment
Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator
Gastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Interventions
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Gastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of gastroparesis and/or functional dyspepsia
* Being prescribed a prokinetic agent or symptom modulator for their clinical care
* Able to undergo BSGM recording both before and during treatment
* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment
Exclusion Criteria
* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Pregnant women
* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved
18 Years
ALL
No
Sponsors
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University of Western Sydney
OTHER
Temple University
OTHER
North Shore Hospital, New Zealand
OTHER
University of Auckland, New Zealand
OTHER
Responsible Party
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Greg O'Grady
MD/PhD
Principal Investigators
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Henry Parkman, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Vincent Ho, MBBS, FRACP, FACP, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Western Sydney
Charlotte Daker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Auckland, New Zealand
Greg O'Grady, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Auckland, New Zealand
Locations
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Temple University
Philadelphia, Pennsylvania, United States
Western Sydney University
Sydney, New South Wales, Australia
Te Whatu Ora Waitemata
Auckland, Auckland, New Zealand
Countries
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Central Contacts
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Facility Contacts
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References
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Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
Other Identifiers
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AK-PRO-001
Identifier Type: -
Identifier Source: org_study_id
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