In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.

• Maternal age ≥18 years.

• Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.

• Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.

• Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.

• Positive evaluation from pediatric neurology consult.

• Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.

Locations
United States
California
University of Southern California / Huntington Memorial Hospital
Recruiting
Los Angeles
Florida
Wellington Regional Medical Center
Recruiting
Wellington
Contact Information
Primary
Ruben Quintero, MD
q@the-fetal-institute.com
720-753-3825
Backup
Ramen Chmait, MD
chmait@usc.edu
626-356-3360
Time Frame
Start Date: November 2, 2018
Estimated Completion Date: December 31, 2027
Participants
Target number of participants: 12
Treatments
Experimental: Fetoscopic repair
Sponsors
Leads: USFetus
Collaborators: Wellington Hospital, University of Southern California

This content was sourced from clinicaltrials.gov

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