Enrolling by invitation NCT06281730
Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Karl Storz New Generation Fetoscope - curved 11508AAK, Karl Storz New Generation Fetoscope - straight 11506AAK.
- Who it may be relevant to
- Registry conditions: In Utero Procedure Affecting Fetus or Newborn. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Adverse events [Time frame: 12 months]
- Serious Adverse Events [Time frame: 12 months]
- Device malfunctions [Time frame: 12 months]
Secondary outcome measures (5)
- Mean gestational age at delivery [Time frame: 12 months]
- Successful Completion [Time frame: 12 months]
- Satisfaction scores [Time frame: 12 months]
- Live births [Time frame: 12 months]
- Neonatal deaths [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT06281730 · 23-009197