A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Purpose

The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

Condition

  • In Utero Procedure Affecting Fetus or Newborn

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pregnant woman - The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition - Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure

Exclusion Criteria

  • Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia - Allergy or previous adverse reaction to a study medication specified in this protocol - Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy - Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation - Suspicion of a major recognized syndrome by ultrasound or MRI - Maternal BMI >40 kg/m2 - High risk for fetal hemophilia

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KARL STORZ fetoscope arm
  • Device: KARL STORZ fetoscope arm
    The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)

Recruiting Locations

The University of Texas health Science Center at Houston
Houston, Texas 77030
Contact:
Jimmy Espinoza, MD, MSc,FACOG
(713) 500-5859
Jimmy.Espinoza@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jimmy Espinoza, MD, MSc,FACOG
(713) 500-5859
Jimmy.Espinoza@uth.tmc.edu

Detailed Description

Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes