Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-03-06 @ 7:06 AM
Study NCT ID:
NCT02165059
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2014-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GI Neuromuscular Pathology Prospective Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Full thickness biopsies of Gastric body and proximal jejunum obtained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes', 'timeFrame': 'from implantation to 6 months after', 'description': 'To determine if ICC abnormalities of the stomach and proximal jejunum can be used as a biologic marker in predicting clinical outcome in patients undergoing surgical implantation of gastric electrical stimulation (GES) for severe gastroparesis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nausea', 'Vomiting', 'Functional dyspepsia', 'Bloating', 'Regurgitation', 'Retching'], 'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).', 'detailedDescription': 'Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Study Group:\n\nPatients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.\n\nInclusion Criteria Control Group:\n\nPatients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery\n\nPatients who are organ donors and undergoing surgery\n\nExclusion Criteria Study Group:\n\nContraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease.\n\nSignificant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners\n\nExclusion Criteria Control Group:\n\nPrior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor'}, 'identificationModule': {'nctId': 'NCT02165059', 'briefTitle': 'GI Neuromuscular Pathology Prospective Registry', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Indiana University GI Neuromuscular Pathology Prospective Registry', 'orgStudyIdInfo': {'id': 'GI Neuromuscular Pathology'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GI Neuromuscal Disorder Cohort', 'description': 'Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder', 'interventionNames': ['Procedure: Surgical Full Thickness Biopsy']}, {'label': 'GI Surgery Patients without neuromuscal disorders (control) cohort', 'description': 'Patients undergoing esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass, whipple surgery, transplant surgery, or organ donors.', 'interventionNames': ['Procedure: Surgical Full Thickness Biopsy']}], 'interventions': [{'name': 'Surgical Full Thickness Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy', 'Surgical', 'Full-thickness', 'Stomach'], 'description': 'Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.', 'armGroupLabels': ['GI Neuromuscal Disorder Cohort', 'GI Surgery Patients without neuromuscal disorders (control) cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Wo', 'role': 'CONTACT', 'email': 'jwo@iu.edu'}, {'name': 'Lainna Cohen', 'role': 'CONTACT', 'email': 'larcohen@iu.edu'}, {'name': 'Tom V Nowak, MD', 'role': 'CONTACT'}, {'name': 'Attila Nakeeb, MD', 'role': 'CONTACT'}, {'name': 'Paul Herring, PhD', 'role': 'CONTACT'}, {'name': 'Muhammad T Idress', 'role': 'CONTACT'}, {'name': 'Chandrashekhar A Kubal, MD', 'role': 'CONTACT'}, {'name': 'Jennifer Choi, MD', 'role': 'CONTACT'}, {'name': 'John M Wo, MD', 'role': 'CONTACT'}], 'facility': 'Indiana University Hosptial', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Maureen Schilling', 'role': 'CONTACT', 'email': 'maschi@iu.edu'}, {'name': 'Lainna Cohen', 'role': 'CONTACT', 'email': 'larcohen@iu.edu'}], 'overallOfficials': [{'name': 'John M Wo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'John M. Wo', 'investigatorAffiliation': 'Indiana University'}}}}