Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy

Enrolling by invitation · Not applicable

Conditions studied: In Utero Procedure Affecting Fetus or Newborn

In brief

The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.

Key facts

Study ID

NCT06281730

Run by

Mayo Clinic

People needed

100

Starts

2024-03-23

Expected to finish

2044-02-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient is a pregnant woman 18 and older
• The mother must be healthy enough to have surgery
• The mother must be scheduled for surgery
• Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure

You may not qualify if…

• Age <18 years
• Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
• Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
• Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.

Where it is running

• Mayo Clinic Minnesota — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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