Flourish™ Pediatric Esophageal Atresia

Cook Group

Status: Completed

Conditions: Esophageal Atresia; Esophageal Disorders Congenital; Digestive System Abnormalities

Treatments: Device: Flourish Pediatric Esphogeal Atresia device

Study type: Observational

Funder types: Industry

Identifiers

NCT03615495

17-09

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterion:

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

Trial design

21 participants in 1 patient group

Flourish device

Description:

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.

Treatment:

Device: Flourish Pediatric Esphogeal Atresia device