Flourish™ Pediatric Esophageal Atresia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03615495 |
Recruitment Status :
Suspended
(Study plan amendment)
First Posted : August 3, 2018
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment |
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Esophageal Atresia Digestive System Abnormalities Esophageal Disorders Congenital | Device: Flourish Pediatric Esphogeal Atresia device |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 20 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish) |
Actual Study Start Date : | November 5, 2018 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | November 2022 |

Group/Cohort | Intervention/treatment |
---|---|
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.
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Device: Flourish Pediatric Esphogeal Atresia 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. |
- Rate of Adverse Events [ Time Frame: 2 years ]Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Has esophageal atresia (EA)
Exclusion Criteria:
- Greater than 1 year of age
- Presence of visible teeth
- Parent or guardian of patient unwilling or unable to provide informed consent for use of data

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615495
United States, Alabama | |
University of Alabama Birmingham/Children's of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Brenner Children's Hospital | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Cincinnati Children's Hospital | |
Cincinnati, Ohio, United States, 54229 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Children's Medical Center | |
Dallas, Texas, United States, 75235 | |
United States, Virginia | |
Carilion Children's Hospital | |
Roanoke, Virginia, United States, 24014 | |
United States, Wisconsin | |
American Family Children's Hospital | |
Madison, Wisconsin, United States, 53792 |
Responsible Party: | Cook Research Incorporated |
ClinicalTrials.gov Identifier: | NCT03615495 |
Other Study ID Numbers: |
17-09 |
First Posted: | August 3, 2018 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Esophageal Atresia Congential |
Esophageal Atresia Esophageal Diseases Digestive System Abnormalities |
Congenital Abnormalities Digestive System Diseases Gastrointestinal Diseases |