Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

Part of paid clinical trials in Los Angeles, California.

Sponsor
USFetus
Study ID
NCT03856034
Status
Recruiting
Apply to this trial

Conditions

  • Chiari Malformation
  • Myelomeningocele
  • Neural Tube Defects
  • Spina Bifida

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetoscopy — DEVICE
    Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).

Study Details

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.

Key Dates

Start date
Nov 2, 2018
Status verified
Nov 2019
Primary completion
Nov 2, 2020
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fetoscopic repair

Primary Outcome Measure

Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques [ Time Frame: At time of surgery until delivery, up to 21 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Southern California / Huntington Memorial HospitalLos AngelesCalifornia91105
Ramen Chmait, MD
[email protected]
626-356-3360
Arlyn Llanes, RN
[email protected]
626-356-3360
Wellington Regional Medical CenterWellingtonFlorida33141
Ruben Quintero, MD
[email protected]
720-753-3825
Eftichia Kontopoulos, MD
[email protected]
720-753-3825

Find similar trials in Los Angeles, CA

By research site
University of Southern California / Huntington Memorial Hospital· Los Angeles, CAWellington Regional Medical Center· Wellington, FL

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