Hernia, DIaphragmatic, CongenitalFETONCT05771688
Fetoscopic Endoluminal Tracheal Occlusion
A study testing FETO therapy in people with Hernia, DIaphragmatic, Congenital, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hernia, DIaphragmatic, Congenital
- What is being tested?
- FETO therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject is defined as a female (18 years or older) who is pregnant.
- The pregnancy must be a singleton pregnancy.
- The CDH must be left-sided.
- The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).
- No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.
- Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects.
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- Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days.
- Cervix length longer than 20 mm at pre-balloon placement evaluation.
- Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis.
- Written consent must be obtained.
- Must meet psychosocial criteria including appropriate family/friend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses.
Who cannot join
- Twin or higher order gestation
- Not able to consent
- Right-sided or bilateral CDH
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Balloon not able to be placed prior to 30 weeks gestation
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- CDH O/E LHR 25% or greater
- Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks)
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures
- Short cervix (20 mm or less)
- History of incompetent cervix or uterine anomaly predisposing to preterm labor
- Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery
- History of natural rubber latex allergy
- No safe or feasible fetoscopic approach to balloon placement
- Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Midwest Fetal Care Center
Minneapolis, Minnesota, 55404
James E Fisher, MD, 612-863-9924, jfisher@pediatricsurgical.com
About this study
Official title: Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia
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.
Read the detailed description
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.
- Conditions
- Hernia, DIaphragmatic, Congenital
- Being tested
- FETO therapy
- Medical subject headings
- Hernia, Diaphragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FETO therapyDevice
Also called Fetoscopic Endoluminal Tracheal Occlusion, GOLDBALLOON, BALTACCI
placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days
| Study group | Role | What they receive |
|---|---|---|
| FETO therapy | Experimental | FETO therapy Receives: Device: FETO therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to 29 weeks 6 days Gestational Age (GA)
Successful removal of Balt Goldbal2 balloon
Removal of the balloon
Measured: Prior to 35 weeks 6 days GA
Secondary outcomes (7)
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.
Measured: Immediately after intervention (device removal)
Gestational age at delivery
Gestational age at delivery will be recorded.
Measured: 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
Measured: Birth - 24 months
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Measured: Birth to 6 months
Number of infants requiring tracheostomy while in the NICU
Tracheostomy information will be collected from medical chart review.
Measured: 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.
Measured: up to 2 years of age
Time to pulmonary hypertension resolution
pulmonary hypertension will be collected from medical chart review.
Measured: up to 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start22 Feb 2024
- Primary completionFeb 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, DIaphragmatic, CongenitalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771688
- Sponsor's protocol ID
- 1397678; 2021-055
- Acronym
- FETO
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT05771688
- Acronym / sponsor ID
- FETO / 1397678; 2021-055
- Conditions
- Hernia, DIaphragmatic, Congenital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- Allina Health System
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Mar 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FETO therapy | Experimental | Device: FETO therapyFETO therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A subject is defined as a female (18 years or older) who is pregnant.
- The pregnancy must be a singleton pregnancy.
- The CDH must be left-sided.
- The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).
- No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.
Key exclusion criteria (15 listed)
- Twin or higher order gestation
- Not able to consent
- Right-sided or bilateral CDH
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
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 |
|---|---|---|
| FETO therapyAlso: Fetoscopic Endoluminal Tracheal Occlusion, GOLDBALLOON, BALTACCIplacement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days | Device | FETO therapy |
Primary outcome
Successful placement of Balt Goldbal2 balloon
Time frame: Prior to 29 weeks 6 days Gestational Age (GA)
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.
Successful removal of Balt Goldbal2 balloon
Time frame: Prior to 35 weeks 6 days GA
Removal of the balloon
7 secondary outcomes
Change in fetal lung growth
Time frame: Immediately after intervention (device removal)
Gestational age at delivery
Time frame: Measured at time of delivery
Infant survival
Time frame: Birth - 24 months
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Time frame: Birth to 6 months
Number of infants requiring tracheostomy while in the NICU
Time frame: up to 2 years of age
Number of infants requiring home oxygen support upon discharge from the NICU
Time frame: up to 2 years of age
Time to pulmonary hypertension resolution
Time frame: up to 2 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FETO therapy in people with Hernia, DIaphragmatic, Congenital, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James E Fisher, MD (612.863.9924, jfisher@pediatricsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful placement of Balt Goldbal2 balloon (time frame: Prior to 29 weeks 6 days Gestational Age (GA)). The study lists 2 primary outcomes in all. 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 23 Feb 2024.