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ACTIVE NOT RECRUITING
NCT03794011
PHASE1

Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

Official title: Study to Compare 2 Minimally Invasive Fetal Neural Tube Defect Repair Techniques: Repair Using Durepair Patch vs. Repair Without Durepair Patch

Key Details

Gender

FEMALE

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2018-12-18

Completion Date

2026-08

Last Updated

2026-02-06

Healthy Volunteers

No

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.

Locations (2)

Stanford University: Lucille Packard's Children's Hospital

Stanford, California, United States

Texas Childrens Hospital

Houston, Texas, United States