Flourish™ Pediatric Esophageal Atresia

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.

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Key information

Conditions

Esophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Esophageal Disorders Congenital Gastrointestinal Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Department of Pediatric Surgery, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criterion:

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

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Aug 3, 2018
Registry last updated: Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed