RECRUITING

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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Conditions

Congenital Diaphragmatic Herniascongenital diaphragmatic herniaFETOtracheal occlusion

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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 rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Official Title

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

Quick Facts

Study Start:2015-09
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02530073

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 CDH with liver up
  5. * Gestation at enrollment prior to 29 wks plus 6 days
  6. * SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%
  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. * Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
  8. * Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Contacts and Locations

Study Contact

Madeline C Crank, NP
CONTACT
972-566-5600
mcrank@fetalcarecenter.md

Principal Investigator

Timothy Crombleholme, MD
PRINCIPAL_INVESTIGATOR
Medical City Children's Hospital

Study Locations (Sites)

Medical City Children's Hospital
Dallas, Texas, 75230
United States

Collaborators and Investigators

Sponsor: Connecticut Children's Medical Center

  • Timothy Crombleholme, MD, PRINCIPAL_INVESTIGATOR, Medical City Children's Hospital

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 Date2015-09
Study Completion Date2030-08

Study Record Updates

Study Start Date2015-09
Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

  • congenital diaphragmatic hernia
  • FETO
  • tracheal occlusion

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernias