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New treatment option for Fetal Conditions
Official title A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
ClinicalTrials.gov ID: NCT06056635
What this study is testing
- What it's testing
- In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Pregnant patient with a condition requiring in-utero surgery
- Patient must be eligible for anesthesia
- Patient and father of the fetus (if available) are able to provide signed informed consent
You likely can't join if
- Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
- Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- Pre-pregnancy maternal BMI greater than 40
- High risk for fetal hemophilia
- Fetal aneuploidy or variants of known significance if an amniocentesis was performed
See the full eligibility criteria
- Pregnant patient with a condition requiring in-utero surgery
- Patient must be eligible for anesthesia
- Patient and father of the fetus (if available) are able to provide signed informed consent
- Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
- Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- Pre-pregnancy maternal BMI greater than 40
- High risk for fetal hemophilia
- Fetal aneuploidy or variants of known significance if an amniocentesis was performed
- Contraindication to abdominal surgery or fetoscopic surgery
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.