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Flourish™ Pediatric Esophageal Atresia

NCT03615495 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-12-06

No results posted yet for this study

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.

Conditions

  • Esophageal Atresia
  • Digestive System Abnormalities
  • Esophageal Disorders Congenital

Interventions

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.

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2023-11-27
Completion
2023-11-27

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615495 on ClinicalTrials.gov