Home › NCT06056635

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Who can join

Ages 18 to 45 · Women

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

About the study

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.

What is being tested

• Karl Storz Curved Scope (device)
• Karl Storz Straight Scope (device)

Sponsor: Boston Children's Hospital · Participants: 50 · Started: Aug 15, 2024

Contact the study team

• Brittany Gudanowski · Phone: 617-919-6658

Official record on ClinicalTrials.gov — NCT06056635

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.