Esophageal AtresiaNCT03615495
Flourish™ Pediatric Esophageal Atresia
An observational study of Esophageal Atresia and Digestive System Abnormalities, run by Cook Research Incorporated at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Esophageal Atresia, Digestive System Abnormalities, Esophageal Disorders Congenital
- What is being tested?
- Flourish Pediatric Esphogeal Atresia device
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 5 Nov 2018to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with esophageal atresia without a tracheoesophageal fistula (TEF) or for whom a concurrent TEF has been closed as a result of a prior procedure.
Who may be able to join
- Patient treated for esophageal atresia with Flourish device starting May 12, 2017
Who cannot join
None listed.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Cincinnati Children's Hospital
Cincinnati, Ohio, 54229
Children's Medical Center
Dallas, Texas, 75235
Hawaii
Honolulu, Hawaii, 96813
American Family Children's Hospital
Madison, Wisconsin, 53792
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Carilion Children's Hospital
Roanoke, Virginia, 24014
St. Louis Children's Hospital
St Louis, Missouri, 63110
Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
Canada1 site
McGill University Department of Pediatric Surgery
Montreal, Quebec, H3G 1A4
About this study
Official title: Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
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.
- Being tested
- Flourish Pediatric Esphogeal Atresia device
- Keywords
- Esophageal, Atresia, Congential
- Medical subject headings
- Esophageal Atresia, Digestive System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourish Pediatric Esphogeal Atresia deviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Flourish Pediatric Esphogeal Atresia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse Events
Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start5 Nov 2018
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615495
- Sponsor's protocol ID
- 17-09
- Status last verified
- Dec 2023
- First submitted
- 31 Jul 2018
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
- ClinicalTrials.gov ID
- NCT03615495
- Acronym / sponsor ID
- 17-09
- Keywords
- Esophageal, Atresia, Congential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flourish device | – | Device: Flourish Pediatric Esphogeal Atresia deviceThe 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. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with esophageal atresia without a tracheoesophageal fistula (TEF) or for whom a concurrent TEF has been closed as a result of a prior procedure.
Key inclusion criteria (1 listed)
- Patient treated for esophageal atresia with Flourish device starting May 12, 2017
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flourish Pediatric Esphogeal Atresia deviceThe 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. | Device | Flourish device |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia and Digestive System Abnormalities, run by Cook Research Incorporated at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.