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

Mayo Clinic

Status: Invitation-only

Conditions: In Utero Procedure Affecting Fetus or Newborn

Treatments: Device: Karl Storz New Generation Fetoscope - straight 11506AAK; Device: Karl Storz New Generation Fetoscope - curved 11508AAK

Study type: Interventional

Funder types: Other

Identifiers

NCT06281730

23-009197

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Karl Storz fetoscopes

Experimental group

Description:

Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.

Treatment:

Device: Karl Storz New Generation Fetoscope - curved 11508AAK

Device: Karl Storz New Generation Fetoscope - straight 11506AAK