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Open Spina Bifida Fetoscopic Repair Project

NCT03562286 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-06-19

No results posted yet for this study

Summary

The aim of the study is to assess a new fetal surgery approach to repair open spina bifida. The fetal group hypothesis is to perform a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair. This approach will allow investigators to make the closure of the defect and avoid the use of an hysterotomy, reducing the risk of maternal complications as uterine dehiscence (rupture), hemorrhage and preterm premature rupture of membranes (PPROM), the patient also will be able to have a vaginal delivery.

Conditions

  • Myelomeningocele

Interventions

PROCEDURE

Fetoscopy

Performing a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair of the fetal neural tube defect.

Sponsors & Collaborators

  • Universidad de Monterrey

    collaborator OTHER

  • Medicina Perinatal Alta Especialidad, México

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Mexico

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 NCT03562286 on ClinicalTrials.gov