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Procedure
Karl Storz fetoscopes for In Utero Procedure
N/A
Recruiting
Led By Mauro Schenone, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is a pregnant woman 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether it is safe and possible to perform surgery on a baby in the womb using new and improved Karl Storz fetoscopes, which are tools to access the baby inside the mother
Who is the study for?
This trial is for pregnant individuals whose babies have been diagnosed with conditions that could potentially be treated through surgery before birth. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and the fetus must be at a stage where in utero surgery is possible.Check my eligibility
What is being tested?
The study is testing new types of fetoscopes by Karl Storz - one curved (11508AAK) and one straight (11506AAK). These tools are designed for surgeries on the baby while still in the womb. The goal is to assess how feasible and safe these procedures are using the new instruments.See study design
What are the potential side effects?
Potential side effects aren't listed, but generally, fetal surgery can carry risks such as preterm labor, rupture of membranes, or complications related to anesthesia. There may also be specific risks associated with using these new fetoscopes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a pregnant woman aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Device malfunctions
Serious Adverse Events
Secondary outcome measures
Live births
Mean gestational age at delivery
Neonatal deaths
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Karl Storz fetoscopesExperimental Treatment2 Interventions
Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,250 Previous Clinical Trials
3,785,258 Total Patients Enrolled
Mauro Schenone, M.D.Principal InvestigatorMayo Clinic
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