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Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

NCT03856034 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-11-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Conditions

  • Neural Tube Defects
  • Spina Bifida
  • Myelomeningocele
  • Chiari Malformation

Interventions

DEVICE

Fetoscopy

Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).

Sponsors & Collaborators

  • Wellington Hospital

    collaborator OTHER_GOV

  • University of Southern California

    collaborator OTHER

  • USFetus

    lead OTHER

Principal Investigators

  • Ruben Quintero, MD · Wellington Regional Medical Center

  • Ramen Chmait, MD · University of Southern California/ Huntington Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-02
Primary Completion
2020-11-02
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856034 on ClinicalTrials.gov