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NCT02230072 · ClinicalTrials.gov registry record · Phase 1

Fetoscopic Meningomyelocele Repair Study

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT02230072: Completed Phase 1 study, sponsored by Baylor College of Medicine.

NCT02230072 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02230072, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women. The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.

Primary Outcome

Whether the minimally invasive technique can be technically performed in human patients (success of primary skin closure) in a safe and effective manner.

Interventions

  • DEVICE fetoscopy

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2014-07-29
Est. Completion 2025-06-23
Phase Phase 1
Baylor College of Medicine

616 total trials

What the finished NCT02230072 record still lists

NCT02230072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which fetoscopy is the first listed.

NCT02230072 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02230072 about?

NCT02230072 is a clinical study titled "Fetoscopic Meningomyelocele Repair Study". The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women. The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the...

What is the current status of trial NCT02230072?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-07-29. Estimated completion is 2025-06-23.

What interventions are being tested in trial NCT02230072?

The interventions under investigation include: fetoscopy (DEVICE).

Who is sponsoring clinical trial NCT02230072?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02230072's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02230072, the US trial registry maintained by the National Library of Medicine. NCT02230072 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.