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Procedure

Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia (TOTAL Trial)

Phase 2 & 3
Waitlist Available
Led By Jan Deprest, MD
Research Sponsored by University Hospital, Gasthuisberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within hospital stay

Summary

This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.

Eligible Conditions
  • Congenital Disorders
  • Pulmonary Hypoplasia
  • Diaphragmatic Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at discharge from neonatal intensive care unit
This trial's timeline: 3 weeks for screening, Varies for treatment, and at discharge from neonatal intensive care unit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Survival at discharge from neonatal intensive care unit
Secondary study objectives
bronchopulmonary dysplasia
number of days in Neonatal Intensive Care Unit (NICU)
occurrence of pulmonary hypertension
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: fetal endoluminal tracheal occlusionExperimental Treatment1 Intervention
fetoscopic balloon occlusion at 27 to 29+6 weeks of gestation
Group II: expectant management during pregnancyPlacebo Group1 Intervention
watchful waiting during pregnancy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fetal endoluminal tracheal occlusion
2011
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

University Hospital, GasthuisbergLead Sponsor
58 Previous Clinical Trials
30,813 Total Patients Enrolled
King's College Hospital NHS Trust (UK)UNKNOWN
1 Previous Clinical Trials
196 Total Patients Enrolled
Hospital Clinic of BarcelonaOTHER
431 Previous Clinical Trials
5,411,217 Total Patients Enrolled
~7 spots leftby Dec 2025
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