Fetoscopic Meningomyelocele Repair Study (fMMC)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02230072|
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : March 20, 2018
The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.
The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defect||Device: fetoscopy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimally Invasive Fetal Neural Tube Defect Repair Study|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2021|
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the fetal open neural tube defect.
- Feasibility [ Time Frame: Time of procedure ]Whether the minimally invasive technique can be technically performed in human patients (success of primary skin closure) in a safe and effective manner.
- Reversal of the Chiari II malformation with complete closure of the spinal defect. [ Time Frame: at birth ]Whether the minimally invasive technique results in an acceptable fetal outcome as defined by reversal of the Chiari II malformation, a reduced need for ventriculoperitoneal shunting or other procedures to avoid or treat hydrocephalus, and complete closure of the spinal defect with protection of the placode. In addition the procedure will be assessed as to whether it prevents loss of neurological level during intra-uterine life.
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): NCT02230072
|Contact: Michael A. Belfort, M.D., Ph.D.||email@example.com|
|Contact: Wyoniquea D. Rahming, MBAfirstname.lastname@example.org|
|United States, California|
|Stanford University: Lucille Packard's Childrens Hospital||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Yair Blumenfeld, MD 650-269-4665 email@example.com|
|Contact: Anna Girsen, PhD 650-725-0499 firstname.lastname@example.org|
|Sub-Investigator: Yasser Y. El-Sayed, MD|
|Sub-Investigator: Gerald Grant, MD|
|Sub-Investigator: Karl G Sylvester, MD,FACS,FAAP|
|Sub-Investigator: Susan Hintz, MD,MS|
|United States, Texas|
|Texas Childrens Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Michael Belfort, M.D. 832-826-7375|
|Principal Investigator: Michael A Belfort, M.D.|
|Sub-Investigator: William E. Whitehead, M.D.|
|Sub-Investigator: Alireza A. Shamshirsaz, M.D.|
|Sub-Investigator: Ahmed Nassr, M.D.|
|Sub-Investigator: Duong D. Tu, M.D.|
|Principal Investigator:||Michael A. Belfort, M.D.||Baylor College of Medicine|