Actively Recruiting
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Led by Boston Children's Hospital · Updated on 2024-09-25
50
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.
CONDITIONS
Official Title
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
B
Brittany Gudanowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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