New scope could revolutionize surgery before birth
NCT ID NCT06281730
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests new, improved fetoscopes—tiny telescopes used to perform surgery on a baby while still in the womb. Researchers at Mayo Clinic will enroll 100 pregnant women to see if the devices are safe and work well. The goal is to improve outcomes for conditions like twin-to-twin transfusion syndrome, but the scopes are not yet FDA-approved.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Karl Storz New Generation Fetoscope (a thin telescope-like device used to perform surgery on a fetus inside the womb)
- What this could lead to
- If successful, this could lead to safer and more effective fetal surgeries for conditions like twin-to-twin transfusion syndrome.
- What could go wrong
- This is an early feasibility study, not a large trial. The devices are not yet FDA-approved, and there are risks to both mother and baby, including preterm labor or surgical complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Feb 2044
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
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