Flourish™ Pediatric Esophageal Atresia

NCT ID: NCT03615495

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-05

Study Completion Date

2023-11-27

Brief Summary

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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

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Conditions

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Esophageal Atresia Digestive System Abnormalities Esophageal Disorders Congenital

Keywords

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Esophageal Atresia Congential

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Flourish Pediatric Esphogeal Atresia device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient treated for esophageal atresia with Flourish device starting May 12, 2017
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hawaii

Honolulu, Hawaii, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Brenner Children's Hospital

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Children's Medical Center

Dallas, Texas, United States

Site Status

Carilion Children's Hospital

Roanoke, Virginia, United States

Site Status

American Family Children's Hospital

Madison, Wisconsin, United States

Site Status

McGill University Department of Pediatric Surgery

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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17-09

Identifier Type: -

Identifier Source: org_study_id