Trials / Completed
CompletedNCT03615495
Flourish™ Pediatric Esophageal Atresia
Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- Cook Research Incorporated · Industry
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-11-05
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
- First posted
- 2018-08-03
- Last updated
- 2023-12-06
Locations
12 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT03615495. Inclusion in this directory is not an endorsement.