Flourish™ Pediatric Esophageal Atresia
Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
1 other identifier
observational
21
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedStudy Start
First participant enrolled
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2023
CompletedDecember 6, 2023
December 1, 2023
5.1 years
July 31, 2018
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Adverse Events
Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks
2 years
Study Arms (1)
Flourish device
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.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (12)
Hawaii
Honolulu, Hawaii, 96813, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Brenner Children's Hospital
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 54229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center
Dallas, Texas, 75235, United States
Carilion Children's Hospital
Roanoke, Virginia, 24014, United States
American Family Children's Hospital
Madison, Wisconsin, 53792, United States
McGill University Department of Pediatric Surgery
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 3, 2018
Study Start
November 5, 2018
Primary Completion
November 27, 2023
Study Completion
November 27, 2023
Last Updated
December 6, 2023
Record last verified: 2023-12