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NCT01240057 · ClinicalTrials.gov registry record · Phase 2
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
A Phase 2 study, sponsored by University Hospital, Gasthuisberg.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT01240057 is a Phase 2 study that has completed, run by University Hospital, Gasthuisberg. The registered enrollment target is 93 participants.
The verdict
NCT01240057, a Phase 2 study, has completed, sponsored by University Hospital, Gasthuisberg.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE fetal endoluminal tracheal occlusion
- OTHER watchful waiting during pregnancy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2011-11 |
| Est. Completion | 2020-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240057
The ClinicalTrials.gov registry entry for NCT01240057 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospital, Gasthuisberg, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which fetal endoluminal tracheal occlusion is the first listed.
NCT01240057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01240057 about?
NCT01240057 is a clinical study titled "Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia". 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.
What is the current status of trial NCT01240057?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2011-11. Estimated completion is 2020-12.
What interventions are being tested in trial NCT01240057?
The interventions under investigation include: fetal endoluminal tracheal occlusion (PROCEDURE), watchful waiting during pregnancy (OTHER).
Who is sponsoring clinical trial NCT01240057?
This trial is sponsored by University Hospital, Gasthuisberg, which has 3 total clinical trials registered on ClinicalTrials.gov.
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