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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06281730
Status
Enrolling By Invitation

Conditions

  • In Utero Procedure Affecting Fetus or Newborn

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 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.

Study Details

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 Dates

Start date
Mar 23, 2024
Status verified
Apr 2026
Primary completion
Feb 29, 2044
Completion
Feb 29, 2044

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Karl Storz fetoscopes
    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 Measure

Adverse events [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905-

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By research site
Mayo Clinic Minnesota· Rochester, MN

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