Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 2:26 AM
Study NCT ID:
NCT05066594
Status:
RECRUITING
Last Update Posted:
2021-10-04
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical use and dosage', 'timeFrame': 'Yearly, up to 5 years from the date of the intervention', 'description': 'Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention'}], 'secondaryOutcomes': [{'measure': 'Health Related Quality of Life questionnaire score', 'timeFrame': 'Yearly, up to 5 years from the date of the intervention', 'description': 'Modification of the scores from the gastro-esophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (absence of symptoms) to 5 (symptoms do not allow for normal daily activity), after intervention compared with baseline'}, {'measure': 'Reflux Symptom Index questionnaire score', 'timeFrame': 'Yearly, up to 5 years from the date of the intervention', 'description': 'Modification of the scores from the reflux symptom index (GERD-RSI) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (no problem) to 5 (severe problem) after the intervention compared with baseline'}, {'measure': 'Esophagitis', 'timeFrame': '6 months and 12 months after the date of the intervention', 'description': 'Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention'}, {'measure': "Hill's grade of the gastro-esophageal flap valve", 'timeFrame': '6 months and 12 months after the date of the intervention', 'description': 'Degree of continence of the neo gastro-esophageal flap valve according to the Hill classification (grade I, grade II, grade III, grade IV) after the intervention'}, {'measure': "Jobe's length of the gastro-esophageal valve", 'timeFrame': '6 months and 12 months after the date of the intervention', 'description': 'Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention'}, {'measure': "Barrett's esophagus", 'timeFrame': '6 months and 12 months after the date of the intervention', 'description': "Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention"}, {'measure': 'High-resolution esophageal manometry findings', 'timeFrame': '12 months after the date of the intervention', 'description': 'Esophageal manometry measurements after the intervention'}, {'measure': '24-hour esophageal pH-metry findings', 'timeFrame': '12 months and 24 months after the date of the intervention', 'description': '24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention'}, {'measure': '24-hour esophageal impedancemetry findings', 'timeFrame': '12 months and 24 months after the date of the intervention', 'description': '24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fundoplication', 'Endoscopy, Digestive System', 'Gastro Esophageal Reflux'], 'conditions': ['Gastro Esophageal Reflux']}, 'descriptionModule': {'briefSummary': 'This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.', 'detailedDescription': 'After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Inclusion criteria for TIF: \\>12 months esophageal or extraesophageal symptoms from gastroesophageal reflux, despite \\>6 months therapy with PPI; cardial valve Hill's degree \\>III; pathological gastroesophageal reflux; hiatal hernia ≤2 cm.\n\nExclusion criteria for TIF: hiatal hernia \\>2 cm; paraesophageal hernia; severe esophageal motility disorder or Los Angeles grade C and D esophagitis; esophageal stenosis, diverticula, infections; pregnancy, breastfeeding; bleeding disorders; malignant neoplasm; immunosuppressant therapy; portal hypertension; esophageal varices; eosinophilic esophagitis; autoimmune esophagitis; BMI ≥35; limited mobility of the neck; patients for whom the use of the EsophyX device is contraindicated.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for enrollment:\n\n* Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;\n* Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;\n* Signed informed consent for participation in the observational registry.\n\nExclusion Criteria for enrollment:\n\n* Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;\n* Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;\n* No signed informed consent for participation in the observational registry.'}, 'identificationModule': {'nctId': 'NCT05066594', 'acronym': 'TIF/2021', 'briefTitle': 'Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'TIF REGISTRY 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)', 'description': 'Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.', 'interventionNames': ['Device: Transoral incisionless fundoplication']}], 'interventions': [{'name': 'Transoral incisionless fundoplication', 'type': 'DEVICE', 'description': 'The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.', 'armGroupLabels': ['Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Alberto Testoni, MD, Prof.', 'role': 'CONTACT', 'email': 'testoni.pieralberto@hsr.it', 'phone': '+39 02/26432756'}, {'name': 'Sabrina Gloria Giulia Testoni, MD, PhD', 'role': 'CONTACT', 'email': 'testoni.sabrinagloriagiulia@hsr.it', 'phone': '+39 02/26436303'}, {'name': 'Pier Alberto Testoni, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sabrina Gloria Giulia Testoni, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sandro Passaretti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emanuela Ribichini, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Pier Alberto Testoni, MD, Prof.', 'role': 'CONTACT', 'email': 'testoni.pieralberto@hsr.it', 'phone': '+39 02/26432756'}, {'name': 'Sabrina Gloria Giulia Testoni, MD, PhD', 'role': 'CONTACT', 'email': 'testoni.sabrinagloriagiulia@hsr.it', 'phone': '+39 02/26436303'}], 'overallOfficials': [{'name': 'Pier Alberto Testoni, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gastroenterology and Digestive Endoscopy', 'investigatorFullName': 'Pier Alberto Testoni', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}