The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-uter… (NCT06425471) | Clinical Trial Compass
RecruitingNot Applicable
The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
United States50 participantsStarted 2024-04-04
Plain-language summary
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
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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
What they're measuring
1
Gestational age at delivery in patients requiring percutaneous in-utero surgery
Timeframe: at time of delivery (about 10 weeks after in utero surgery)
Trial details
NCT IDNCT06425471
SponsorThe University of Texas Health Science Center, Houston