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

Not Applicable

• Conditions: In Utero Procedure Affecting Fetus or Newborn
• Interventions: Device: Karl Storz New Generation Fetoscope - curved 11508AAK; Device: Karl Storz New Generation Fetoscope - straight 11506AAK

• Registration Number: NCT06281730
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2024-03-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2044-02
• Study Completion: 2044-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Karl Storz fetoscopes	Karl Storz New Generation Fetoscope - curved 11508AAK	Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.
Karl Storz fetoscopes	Karl Storz New Generation Fetoscope - straight 11506AAK	Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.

Primary Outcome Measures

Name	Time	Method
Device malfunctions	12 months	The number of device malfunction incidents
Adverse events	12 months	The count of subjects who experience adverse events
Serious Adverse Events	12 months	The count of subjects who experience serious adverse events

Secondary Outcome Measures

Name	Time	Method
Successful Completion	12 months	The number of successful fetoscopic surgeries in twin twin transfusion syndrome. The measure of success is being able to ablate all anastomoses thought to be involved in causing the twin twin transfusion syndrome.
Satisfaction scores	12 months	Surgeon reported satisfaction of the use of the Karl Storz fetoscopes as measured by a 3 item Likert scale questionnaire. The 3 items are scored from 0 - 3, 0 being strongly disagree to 3 being strongly agree. Total scores range from 0 - 9, lower scores indicate less satisfaction, and higher scores indicate more satisfaction.
Mean gestational age at delivery	12 months	The mean gestational age at delivery. Measured in weeks.
Live births	12 months	The number of subjects to have a live birth following in-utero surgery
Neonatal deaths	12 months	The number of subjects who experience a neonate death following in-utero surgery

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States