Home › NCT06425471
The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Recruiting
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Who can join
Ages 18 to 45 · Women
Full eligibility criteria
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
About the study
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
What is being tested
- KARL STORZ fetoscope arm (device)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 50 · Started: Apr 4, 2024
Contact the study team
- Jimmy Espinoza, MD, MSc,FACOG · Phone: (713) 500-5859
- Elisa Garcia · Phone: 713-500-6347
Official record on ClinicalTrials.gov — NCT06425471
Locations in the U.S.
| Texas | The University of Texas health Science Center at Houston, Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.