In Utero Procedure Affecting Fetus or Newborn
Conditions
Keywords
Fetoscopes
Brief 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.
Interventions
DEVICEKarl 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.
DEVICEKarl 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
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months | The count of subjects who experience adverse events |
| Serious Adverse Events | 12 months | The count of subjects who experience serious adverse events |
| Device malfunctions | 12 months | The number of device malfunction incidents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean gestational age at delivery | 12 months | The mean gestational age at delivery. Measured in weeks. |
| Successful Completion | 12 months | The number of successful fetoscopic surgeries in twin twin transfusion syndrome. The measure of success is being able to ablate all anastomoses thought to be involved in causing the twin twin transfusion syndrome. |
| Satisfaction scores | 12 months | Surgeon reported satisfaction of the use of the Karl Storz fetoscopes as measured by a 3 item Likert scale questionnaire. The 3 items are scored from 0 - 3, 0 being strongly disagree to 3 being strongly agree. Total scores range from 0 - 9, lower scores indicate less satisfaction, and higher scores indicate more satisfaction. |
| Live births | 12 months | The number of subjects to have a live birth following in-utero surgery |
| Neonatal deaths | 12 months | The number of subjects who experience a neonate death following in-utero surgery |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMauro Schenone, M.D.
Mayo Clinic
Outcome results
None listed