Flourish™ Pediatric Esophageal Atresia

Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)

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 Overview

• Status: Completed
• Conditions: Digestive System Abnormalities; Esophageal Atresia; Esophageal Disorders Congenital
• Intervention / Treatment: Device: Flourish Pediatric Esphogeal Atresia device

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • McGill University Department of Pediatric Surgery
• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Brenner Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 54229
      • Cincinnati Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Children's Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • American Family Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criterion:

• Patient treated for esophageal atresia with Flourish device starting May 12, 2017

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Esophageal; Atresia; Congential
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Atresia; Digestive System Abnormalities
• Other Study ID Numbers: 17-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• 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