MedTrace Logo

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

NCT06281730 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

DEVICE

Karl Storz New Generation Fetoscope - curved 11508AAK

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.

DEVICE

Karl Storz New Generation Fetoscope - straight 11506AAK

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.

Sponsors & Collaborators

Principal Investigators

  • Mauro Schenone, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-23
Primary Completion
2044-02-29
Completion
2044-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281730 on ClinicalTrials.gov