An interventional study of FETO therapy in Hernia, DIaphragmatic, Congenital, sponsored by Children's Hospitals and Clinics of Minnesota. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Children's Hospitals and Clinics of Minnesota · Not applicable, Interventional, and Device feasibility
Slow Recruitment, business/study personnel change
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.
This is a single site pilot trial to assess the feasibility and safety of treating the most severe group of fetuses with left CDH with Fetal Endoluminal Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Midwest Fetal Care Center (MWFCC), a collaboration between Allina Health and Children's MN.
Congenital Diaphragmatic Hernia (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 in the lungs and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life. The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore neonatal survival.
The study will enroll pregnant women that meet study criteria, and their baby. The mother-fetus participant will undergo one procedure for placement of FETO before gestational age 29 weeks 6 days; and a second procedure for removal of the FETO device. The timing for removal of FETO is no later than 35 weeks and 6 days. After delivery, routine care of the baby with CDH will occur within the Children's MN NICU.
23 studies on the registry are indexed under Hernia, Diaphragmatic; 4 are open to participants now.
Browse Hernia, Diaphragmatic studies →Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FETO therapy
Device: FETO therapy
placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days
Also known as: Fetoscopic Endoluminal Tracheal Occlusion, GOLDBALLOON, BALTACCI
Successful placement of Balt Goldbal2 balloon
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Time frame: Prior to 29 weeks 6 days Gestational Age (GA)
Successful removal of Balt Goldbal2 balloon
Removal of the balloon
Time frame: Prior to 35 weeks 6 days GA
Change in fetal lung growth
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Time frame: Immediately after intervention (device removal)
Gestational age at delivery
Gestational age at delivery will be recorded.
Time frame: Measured at time of delivery
Infant survival
Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age
Time frame: Birth - 24 months
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Time frame: Birth to 6 months
Number of infants requiring tracheostomy while in the NICU
Tracheostomy information will be collected from medical chart review.
Time frame: up to 2 years of age
Number of infants requiring home oxygen support upon discharge from the NICU
Oxygen support will be collected from medical chart review.
Time frame: up to 2 years of age
Time to pulmonary hypertension resolution
pulmonary hypertension will be collected from medical chart review.
Time frame: up to 2 years of age
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Feb 2026, 24 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Feb 2028 → Feb 2026 and completion Sep 2028 → Feb 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
Slow Recruitment, business/study personnel change
Slow Recruitment, business/study personnel change
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospitals and Clinics of Minnesota