RECRUITING

Fetoscopic Endoluminal Tracheal Occlusion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Official Title

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)

Quick Facts

Study Start:2018-11-16
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03674372

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women age 18 years and older, who are able to consent
  2. * Singleton pregnancy
  3. * Normal Karyotype
  4. * Fetal Diagnosis of Isolated Left or Right CDH with liver up
  5. * Gestation at enrollment prior to 29 wks plus 6 days
  6. * SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45%
  1. * Pregnant women \<18 years of age.
  2. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  3. * Technical limitations precluding fetoscopic surgery
  4. * Rubber latex allergy
  5. * Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
  6. * Psychosocial ineligibility, precluding consent
  7. * Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Contacts and Locations

Study Contact

Elizabeth Torres
CONTACT
720-777-1661
elizabeth.torres@childrenscolorado.org
Halley Isberg
CONTACT
720-777-9514
halley.isberg@childrenscolorado.org

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-16
Study Completion Date2030-03

Study Record Updates

Study Start Date2018-11-16
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • tracheal occlusion
  • FETO
  • Congenital Diaphragmatic Hernia

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernia