Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-28 @ 12:51 PM
Study NCT ID:
NCT03615495
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flourish™ Pediatric Esophageal Atresia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004933', 'term': 'Esophageal Atresia'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Adverse Events', 'timeFrame': '2 years', 'description': 'Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal', 'Atresia', 'Congential'], 'conditions': ['Esophageal Atresia', 'Digestive System Abnormalities', 'Esophageal Disorders Congenital']}, 'descriptionModule': {'briefSummary': 'This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with esophageal atresia without a tracheoesophageal fistula (TEF) or for whom a concurrent TEF has been closed as a result of a prior procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criterion:\n\n* Patient treated for esophageal atresia with Flourish device starting May 12, 2017'}, 'identificationModule': {'nctId': 'NCT03615495', 'briefTitle': 'Flourish™ Pediatric Esophageal Atresia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)', 'orgStudyIdInfo': {'id': '17-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Flourish device', 'description': 'The Flourish Pediatric Esophageal Atresia device is indicated for use in lengthening atretic esophageal ends and creating an anastomosis with a non-surgical procedure in pediatric patients.', 'interventionNames': ['Device: Flourish Pediatric Esphogeal Atresia device']}], 'interventions': [{'name': 'Flourish Pediatric Esphogeal Atresia device', 'type': 'DEVICE', 'description': 'The Flourish Pediatric Esophageal Atresia device consists of an esophageal catheter and a gastric catheter. Both catheters are equipped with an inner magnet catheter. When the esophageal and gastric catheters are aligned tip to tip, the magnets attract.', 'armGroupLabels': ['Flourish device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Brenner Children's Hospital", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '54229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': "Carilion Children's Hospital", 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "American Family Children's Hospital", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Department of Pediatric Surgery', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Research Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}