Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| USFetus | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Technique | Experimental | The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery. |
|
| Laparotomy/Uterine Exteriorization Technique | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique | Device | The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to perform the endoscopic procedure | Successful fetoscopic closure of the defect | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Chiari II malformation reversal | Reversal of hindbrain herniation on ultrasound and MRI | Prior to delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Gravid female
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ruben Quintero, MD | US Fetus | Principal Investigator |
| Ramen Chmait, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollywood Presbyterian Medical Center | Los Angeles | California | 90027 | United States | ||
| Wellington Regional Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique | Device | The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction. |
|
| Wellington |
| Florida |
| 33141 |
| United States |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D016135 | Spinal Dysraphism |
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided