RECRUITING

The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Description

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

Conditions

In Utero Procedure Affecting Fetus or Newborn
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Related Conditions:

In Utero Procedure Affecting Fetus or Newborn

Study Overview

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Study Details

Study overview

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

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

The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Condition
In Utero Procedure Affecting Fetus or Newborn
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Jimmy Espinoza, MD, MSc,FACOG, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2027-12-31