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NCT03615495 · ClinicalTrials.gov registry record
Flourish™ Pediatric Esophageal Atresia
A clinical trial, sponsored by Cook Research Incorporated.
- Completed
- Registry status
- 21
- Enrollment target
NCT03615495: Completed study, sponsored by Cook Research Incorporated.
NCT03615495 is a clinical trial that has completed, run by Cook Research Incorporated. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03615495 has completed, sponsored by Cook Research Incorporated.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
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.
Primary Outcome
Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks
Interventions
- DEVICE Flourish Pediatric Esphogeal Atresia device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2023-11-27 |
What the finished NCT03615495 record still lists
NCT03615495 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Flourish Pediatric Esphogeal Atresia device is the first listed.
NCT03615495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03615495 about?
NCT03615495 is a clinical study titled "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.
What is the current status of trial NCT03615495?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2018-11-05. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT03615495?
The interventions under investigation include: Flourish Pediatric Esphogeal Atresia device (DEVICE).
Who is sponsoring clinical trial NCT03615495?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
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