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NCT02875860 · ClinicalTrials.gov registry record · Phase 2
'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
A Phase 2 study, sponsored by Michael A Belfort.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT02875860: Completed Phase 2 study, sponsored by Michael A Belfort.
NCT02875860 is a Phase 2 study that has completed, run by Michael A Belfort. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02875860, a Phase 2 study, has completed, sponsored by Michael A Belfort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.
Primary Outcome
The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO).
Interventions
- DEVICE GoldBal2 detachable balloon
- DEVICE Baltaccidbpe100 Delivery Catheter
- OTHER Standardized postnatal care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-01 |
| Est. Completion | 2019-10 |
| Phase | Phase 2 |
What the finished NCT02875860 record still lists
NCT02875860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which GoldBal2 detachable balloon is the first listed.
NCT02875860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02875860 about?
NCT02875860 is a clinical study titled "'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial". This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.
What is the current status of trial NCT02875860?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2017-01. Estimated completion is 2019-10.
What interventions are being tested in trial NCT02875860?
The interventions under investigation include: GoldBal2 detachable balloon (DEVICE), Baltaccidbpe100 Delivery Catheter (DEVICE), Standardized postnatal care (OTHER).
Who is sponsoring clinical trial NCT02875860?
This trial is sponsored by Michael A Belfort, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02875860's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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