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.
Study Type
OBSERVATIONAL
Enrollment
21
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.
Hawaii
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Rate of Adverse Events
Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks
Time frame: 2 years
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Boston Children's Hospital
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Brenner Children's Hospital
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center
Dallas, Texas, United States
Carilion Children's Hospital
Roanoke, Virginia, United States
...and 2 more locations