Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
Status: Completed
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:
• Patient treated for esophageal atresia with Flourish device starting May 12, 2017
Locations
United States
Hawaii
Hawaii
Honolulu
Illinois
Rush University Medical Center
Chicago
University of Chicago Medical Center
Chicago
Massachusetts
Boston Children's Hospital
Boston
Missouri
St. Louis Children's Hospital
St Louis
North Carolina
Brenner Children's Hospital
Winston-salem
Ohio
Cincinnati Children's Hospital
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Texas
Children's Medical Center
Dallas
Virginia
Carilion Children's Hospital
Roanoke
Wisconsin
American Family Children's Hospital
Madison
Other Locations
Canada
McGill University Department of Pediatric Surgery
Montreal
Time Frame
Start Date: 2018-11-05
Completion Date: 2023-11-27
Participants
Target number of participants: 21
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Cook Research Incorporated