Evaluating new fetoscopes for in-utero surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.