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Flourish™ Pediatric Esophageal Atresia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615495
Recruitment Status : Suspended (Study plan amendment)
First Posted : August 3, 2018
Last Update Posted : November 20, 2020
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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