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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615495
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

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.

Condition or disease Intervention/treatment
Esophageal Atresia Digestive System Abnormalities Esophageal Disorders Congenital Device: Flourish Pediatric Esphogeal Atresia device

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615495


Contacts
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Contact: Julie Whitaker 800.356.9208 ext 321549 Julie.Whitaker@cookmedical.com

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Cincinnati Children's Hospital Recruiting
Cincinnati, Illinois, United States, 54229
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Brenner Children's Hospital Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center Not yet recruiting
Dallas, Texas, United States, 75235
United States, Wisconsin
American Family Children's Hospital Not yet recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Cook Research Incorporated

Additional Information:

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT03615495     History of Changes
Other Study ID Numbers: 17-09
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Esophageal
Atresia
Congential
Additional relevant MeSH terms:
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Esophageal Atresia
Esophageal Diseases
Digestive System Abnormalities
Congenital Abnormalities
Digestive System Diseases
Gastrointestinal Diseases