Flourish™ Pediatric Esophageal Atresia

• ClinicalTrials.gov Identifier: NCT03615495
• Recruitment Status: Suspended
• First Posted: August 3, 2018
• Last Update Posted: November 20, 2020
• Sponsor: Cook Research Incorporated
• Information provided by (Responsible Party): Cook Group Incorporated ( Cook Research Incorporated )

Tracking Information

• First Submitted Date: July 31, 2018
• First Posted Date: August 3, 2018
• Last Update Posted Date: November 20, 2020
• Actual Study Start Date: November 5, 2018
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2018)

Rate of Adverse Events [ Time Frame: 2 years ]

Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Flourish™ Pediatric Esophageal Atresia
• Official Title: Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure.

Condition

• Esophageal Atresia
• Digestive System Abnormalities
• Esophageal Disorders Congenital

Intervention

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.

Study Groups/Cohorts

Flourish device

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.

Intervention: Device: Flourish Pediatric Esphogeal Atresia device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: August 2, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2022
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Has esophageal atresia (EA)

Exclusion Criteria:

• Greater than 1 year of age
• Presence of visible teeth
• Parent or guardian of patient unwilling or unable to provide informed consent for use of data

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 12 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03615495
• Other Study ID Numbers: 17-09
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

• Responsible Party: Cook Group Incorporated ( Cook Research Incorporated )
• Study Sponsor: Cook Research Incorporated
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cook Group Incorporated
• Verification Date: November 2020