Flourish™ Pediatric Esophageal Atresia

Completed

• Conditions: Digestive System Abnormalities; Esophageal Disorders Congenital; Esophageal Atresia
• Interventions: Device: Flourish Pediatric Esphogeal Atresia device

• Registration Number: NCT03615495
• Lead Sponsor: Cook Research Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Study Start: 2018-11-05
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Flourish device	Flourish Pediatric Esphogeal Atresia 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.

Primary Outcome Measures

Name	Time	Method
Rate of Adverse Events	2 years	Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks

Trial Locations

Locations (12)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Hawaii; 🇺🇸 Honolulu, Hawaii, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States

Children's Medical Center; 🇺🇸 Dallas, Texas, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Carilion Children's Hospital; 🇺🇸 Roanoke, Virginia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Brenner Children's Hospital; 🇺🇸 Winston-Salem, North Carolina, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

McGill University Department of Pediatric Surgery; 🇨🇦 Montréal, Quebec, Canada