Using curved and straight fetoscopes for in-utero surgery
Official title: A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Run by The University of Texas Health Science Center, Houston · NCT06425471 · Data updated 2026-11-12
This study is testing whether using a curved fetoscope for in-utero surgeries can lead to better outcomes for fetuses and newborns compared to using a straight fetoscope or no fetoscope at all.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | April 4, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | August 14, 2025 |
| Trial ID | NCT06425471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women who meet the criteria for in-utero surgery based on their specific medical conditions.
✕Probably not a fit
Patients who may not benefit from this study include those with contraindications to surgery, significant fetal anomalies, or maternal health issues that complicate the procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of the KARL STORZ curved fetoscope and its straight version for performing in-utero surgeries. It will prospectively compare outcomes from patients undergoing these procedures with the fetoscopes to historical control data from patients who had similar surgeries without the use of these instruments. The goal is to determine if the curved fetoscope improves surgical outcomes for fetuses and newborns.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of in-utero surgeries, potentially improving outcomes for affected fetuses and newborns.
How similar studies have gone: While this approach is innovative, it is based on historical data, and similar studies have not been widely reported, making this a potentially novel investigation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The University of Texas health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Jimmy Espinoza, MD, MSc,FACOG — The University of Texas Health Science Center, Houston
- Study coordinator: Jimmy Espinoza, MD, MSc,FACOG
- Email: Jimmy.Espinoza@uth.tmc.edu
- Phone: (713) 500-5859
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.