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NCT03615495 Clinical Trial

Flourish™ Pediatric Esophageal Atresia

Esophageal Atresia Clinical Trial

Official title:
Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03615495
Other study ID # 17-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 5, 2018
Est. completion date November 27, 2023

Study information
Verified date December 2023
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date November 27, 2023
Est. primary completion date November 27, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criterion: - Patient treated for esophageal atresia with Flourish device starting May 12, 2017

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada McGill University Department of Pediatric Surgery Montréal Quebec
United States Boston Children's Hospital Boston Massachusetts
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Children's Medical Center Dallas Texas
United States Hawaii Honolulu Hawaii
United States American Family Children's Hospital Madison Wisconsin
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Carilion Children's Hospital Roanoke Virginia
United States St. Louis Children's Hospital Saint Louis Missouri
United States Brenner Children's Hospital Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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