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Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

NCT03794011 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-06

No results posted yet for this study

Summary

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique.

The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.

Conditions

  • Neural Tube Defects

Interventions

DEVICE

fetoscopy

The fetoscopic arm is described above. Patients who have an appropriate window (posterior placenta) and choose fetoscopic surgery will be offered the two fetoscopic options, (i) laparotomy assisted and, (ii) totally percutaneous expandable port assisted. Patients with an anterior placenta will only be offered the lapartotomy assisted approach. All patients will undergo a fetoscopic repair of the fetal open neural tube defect including a the use of a Durepair patch.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Michael A. Belfort, M.D., Ph.D. · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03794011 on ClinicalTrials.gov