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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.