Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flourish Pediatric Esphogeal Atresia device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criterion:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawaii | Honolulu | Hawaii | 96813 | United States | ||
| Rush University Medical Center |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| D004065 | Digestive System Abnormalities |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided