Evaluating new fetoscopes for in-utero surgery
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
This study is testing two new types of fetoscopes to see which one works better for performing safe surgeries on unborn babies with certain health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06056635 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Karl Storz curved and straight fetoscopes in performing fetoscopic intrauterine procedures. The curved scope is designed for patients with an anterior placenta, while the straight scope is for those with a posterior placenta. The fetoscopes will assist in minimally invasive surgeries, such as fetoscopic laser photocoagulation, to treat various fetal conditions like twin-twin transfusion syndrome and other congenital anomalies. The study will analyze surgical outcomes, complications, and the overall impact on maternal and fetal health. Data will be collected through descriptive statistical analysis to evaluate the benefits of these innovative devices.
Who should consider this trial
Good fit: Ideal candidates include pregnant patients with conditions requiring in-utero surgery who are eligible for anesthesia.
Not a fit: Patients with contraindications to abdominal or fetoscopic surgery, or those with significant maternal or fetal health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for pregnant patients undergoing in-utero procedures.
How similar studies have performed: Other studies have shown that advancements in fetoscopic techniques and equipment can lead to better outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Eyal Krispin, MD — Fetal Surgeon
- Study coordinator: Brittany Gudanowski
- Email: Brittany.Gudanowski@childrens.harvard.edu
- Phone: 617-919-6658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.