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

NCT06281730 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 23-009197
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

In Utero Procedure Affecting Fetus or Newborn

Keywords

Fetoscopes

Outcome Measures

Primary Outcomes (3)

• Adverse events

  The count of subjects who experience adverse events

  12 months

• Serious Adverse Events

  The count of subjects who experience serious adverse events

  12 months

• Device malfunctions

  The number of device malfunction incidents

  12 months

Secondary Outcomes (5)

• Mean gestational age at delivery

  12 months

• Successful Completion

  12 months

• Satisfaction scores

  12 months

• Live births

  12 months

• Neonatal deaths

  12 months

Study Arms (1)

Karl Storz fetoscopes

EXPERIMENTAL

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

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

Interventions

Karl Storz New Generation Fetoscope - curved 11508AAK DEVICE

11508AAK Miniature straight forward telescope 0-degree set, curved, diameter 3.3 millimeter, length 30 centimeter, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 French., remote eyepiece, fiber optic light transmission incorporated.

Karl Storz fetoscopes

Karl Storz New Generation Fetoscope - straight 11506AAK DEVICE

11506AAK Miniature straight forward telescope 0-degree, straight, diameter 3.3 millimeter, length 30 cm, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 french, remote eyepiece, fiber optic light transmission incorporated.

Karl Storz fetoscopes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Mauro Schenone, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: March 23, 2024
• Primary Completion (Estimated): February 1, 2044
• Study Completion (Estimated): February 1, 2044
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)