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Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

NCT04356703 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-04-22

No results posted yet for this study

Summary

Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30 months or more, regarding ambulation, neurodevelopment, urinary and fecal status.

Conditions

  • Open Spina Bifida
  • Myelomeningocele
  • Meningomyelocele
  • Chiari Malformation With Spina Bifida
  • Chiari Malformation Type 2

Interventions

OTHER

Neuropsicomotor developmental test

Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • DENISE A LAPA, MD · Hospital Israelita Albert Einstein

Eligibility

Min Age
12 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-09-30
Completion
2020-03-01

Countries

  • Brazil

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 NCT04356703 on ClinicalTrials.gov