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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • KARL STORZ fetoscope arm

Treatment groups

50 Participants
are divided into 1 treatment group