Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06854120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-08-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).', 'timeFrame': '8 weeks'}, {'measure': 'Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).', 'timeFrame': '8 weeks'}, {'measure': 'Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gastroparesis', 'Functional Dyspepsia', 'Gastric Motility', 'Body Surface Gastric Mapping'], 'conditions': ['Gastroparesis', 'Functional Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '36534985', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '37782524', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '36130019', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age and older\n* Diagnosis of gastroparesis and/or functional dyspepsia\n* Being prescribed a prokinetic agent or symptom modulator for their clinical care\n* Able to undergo BSGM recording both before and during treatment\n* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)\n* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions\n* Pregnant women\n* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved'}, 'identificationModule': {'nctId': 'NCT06854120', 'briefTitle': 'Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects', 'organization': {'class': 'OTHER', 'fullName': 'University of Auckland, New Zealand'}, 'officialTitle': 'Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy', 'orgStudyIdInfo': {'id': 'AK-PRO-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator', 'interventionNames': ['Device: Gastric Alimetry']}], 'interventions': [{'name': 'Gastric Alimetry', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Henry Parkman, PhD/MD', 'role': 'CONTACT', 'email': 'henry.parkman@temple.edu', 'phone': '800-836-7536'}, {'name': 'Henry Parkman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '2560', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'contacts': [{'name': 'Daphne Foong, PhD', 'role': 'CONTACT', 'email': 'd.foong@westernsydney.edu.au', 'phone': '+61 2 4634 4579'}, {'name': 'Vincent Ho, MBBS, FRACP, FACP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Sydney University', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '0622', 'city': 'Auckland', 'state': 'Auckland', 'country': 'New Zealand', 'contacts': [{'name': 'Charlotte Daker, MD', 'role': 'CONTACT', 'email': 'Charlotte.Daker@waitematadhb.govt.nz', 'phone': '+64 21 349 305'}, {'name': 'Charlotte Daker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Te Whatu Ora Waitemata', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'centralContacts': [{'name': 'Genevieve M Johnston, PhD', 'role': 'CONTACT', 'email': 'gen.johnston@auckland.ac.nz', 'phone': '+64 9 373 7599'}], 'overallOfficials': [{'name': 'Henry Parkman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}, {'name': 'Vincent Ho, MBBS, FRACP, FACP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Sydney'}, {'name': 'Charlotte Daker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Auckland, New Zealand'}, {'name': "Greg O'Grady, MD, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Auckland, New Zealand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study design means that no identifiable data will be shared beyond immediate study researchers at each location.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Auckland, New Zealand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Sydney', 'class': 'OTHER'}, {'name': 'Temple University', 'class': 'OTHER'}, {'name': 'North Shore Hospital, New Zealand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD/PhD', 'investigatorFullName': "Greg O'Grady", 'investigatorAffiliation': 'University of Auckland, New Zealand'}}}}