Flourish™ Pediatric Esophageal Atresia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03615495

Enrollment

Registered

2018-08-03

Start date

2018-11-05

Completion date

2023-11-27

Last updated

2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Abnormalities, Esophageal Atresia, Esophageal Disorders Congenital

Keywords

Esophageal, Atresia, Congential

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.

Interventions

DEVICEFlourish 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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

Healthy volunteers

Inclusion criteria

Inclusion Criterion: * Patient treated for esophageal atresia with Flourish device starting May 12, 2017

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026