RECRUITING

Fetoscopic Endoluminal Tracheal Occlusion

Conditions

Quick Navigation

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

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.

Official Title

Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia

Quick Facts

Study Start:2024-02-22

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05771688

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 Criteria	Exclusion Criteria
1. A subject is defined as a female (18 years or older) who is pregnant. 2. The pregnancy must be a singleton pregnancy. 3. The CDH must be left-sided. 4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - \< 25% from U/S measurements). 5. No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype. 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects. 7. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days. 8. Cervix length longer than 20 mm at pre-balloon placement evaluation. 9. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis. 10. Written consent must be obtained. 11. 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.	1. Twin or higher order gestation 2. Not able to consent 3. Right-sided or bilateral CDH 4. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome 5. Maternal isoimmunization or neonatal alloimmune thrombocytopenia 6. Balloon not able to be placed prior to 30 weeks gestation 7. CDH O/E LHR 25% or greater 8. 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) 9. 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 10. Short cervix (20 mm or less) 11. History of incompetent cervix or uterine anomaly predisposing to preterm labor 12. Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery 13. History of natural rubber latex allergy 14. No safe or feasible fetoscopic approach to balloon placement 15. Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota

Inclusion Criteria

Exclusion Criteria

1. A subject is defined as a female (18 years or older) who is pregnant.
2. The pregnancy must be a singleton pregnancy.
3. The CDH must be left-sided.
4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - \< 25% from U/S measurements).
5. No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.
6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects.
7. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days.
8. Cervix length longer than 20 mm at pre-balloon placement evaluation.
9. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis.
10. Written consent must be obtained.
11. 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.

1. Twin or higher order gestation
2. Not able to consent
3. Right-sided or bilateral CDH
4. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
5. Maternal isoimmunization or neonatal alloimmune thrombocytopenia
6. Balloon not able to be placed prior to 30 weeks gestation
7. CDH O/E LHR 25% or greater
8. 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)
9. 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
10. Short cervix (20 mm or less)
11. History of incompetent cervix or uterine anomaly predisposing to preterm labor
12. Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery
13. History of natural rubber latex allergy
14. No safe or feasible fetoscopic approach to balloon placement
15. Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota

Contacts and Locations

Study Contact

James E Fisher, MD

CONTACT

612.863.9924

jfisher@pediatricsurgical.com

Study Locations (Sites)

Midwest Fetal Care Center

Minneapolis, Minnesota, 55404

United States

Collaborators and Investigators

Sponsor: Children's Hospitals and Clinics of Minnesota

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 Date2024-02-22

Study Completion Date2028-09

Study Record Updates

Study Start Date2024-02-22

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

Hernia, DIaphragmatic, Congenital