Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
NCT Number: NCT06281730
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 months
The count of subjects who experience adverse events
Time frame: 12 months
The count of subjects who experience serious adverse events
Time frame: 12 months
The number of device malfunction incidents
Time frame: 12 months
The mean gestational age at delivery. Measured in weeks.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
The number of subjects to have a live birth following in-utero surgery
Time frame: 12 months
The number of subjects who experience a neonate death following in-utero surgery
Mayo Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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