Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03794011|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : April 5, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defects||Device: fetoscopy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Compare 2 Minimally Invasive Fetal Neural Tube Defect Repair Techniques: Repair Using Durepair Patch vs. Repair Without Durepair Patch|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||August 2026|
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
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.
- MMC Repair Dehiscence and/or CSF leak [ Time Frame: at birth ]Rate of MMC repair dehiscence and/or CSF leak in each group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794011
|United States, California|
|Stanford University: Lucille Packard's Children's Hospital|
|Stanford, California, United States, 94305|
|United States, Texas|
|Texas Childrens Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael A. Belfort, M.D., Ph.D.||Baylor College of Medicine|