In-Utero Endoscopic Correction of Spina Bifida
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|ClinicalTrials.gov Identifier: NCT04362592|
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defects Spina Bifida Myelomeningocele||Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||In-Utero Endoscopic Correction of Spina Bifida: Laparotomy or Percutaneous|
|Actual Study Start Date :||November 2, 2018|
|Estimated Primary Completion Date :||November 2, 2022|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Percutaneous Technique
The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery.
Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique
The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.
Experimental: Laparotomy/Uterine Exteriorization Technique
The laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction.
Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique
The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.
- Ability to perform the endoscopic procedure [ Time Frame: At time of surgery ]Successful fetoscopic closure of the defect
- Chiari II malformation reversal [ Time Frame: Prior to delivery ]Reversal of hindbrain herniation on ultrasound and MRI
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): NCT04362592
|Contact: Ruben Quintero, MDfirstname.lastname@example.org|
|Principal Investigator:||Ruben Quintero, MD||US Fetus|
|Principal Investigator:||Ramen Chmait, MD||University of Southern California|