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N/A
Flourish™ Pediatric Esophageal Atresia
N/A
Waitlist Available
Research Sponsored by Cook Research Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patient treated for esophageal atresia with Flourish device starting May 12, 201
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Esophageal Atresia
- Digestive Abnormalities
- Digestive Disorders
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Flourish deviceExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Flourish Pediatric Esphogeal Atresia device
2018
N/A
~30
Find a Location
Who is running the clinical trial?
Cook Research IncorporatedLead Sponsor
30 Previous Clinical Trials
253,846 Total Patients Enrolled