What is this study trying to find out about fetal conditions?

This study is evaluating new curved and straight fetoscopes used in minimally invasive in-utero surgeries for fetal conditions like twin-twin transfusion syndrome. Researchers want to learn how these devices affect surgical outcomes and complications during pregnancy. The trial is sponsored by Boston Children's Hospital and aims to improve fetal surgery techniques.

Who may be eligible for this fetal condition clinical trial?

Women aged 18 to 45 who are pregnant and require in-utero surgery may be eligible. They must be able to safely undergo anesthesia and provide informed consent. Patients with certain pregnancy complications or allergies to surgery medications may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this fetal condition clinical trial?

Study-related care, including the use of the fetoscopes and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 45Years

FEMALE

ID06056635

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes for Fetoscopic Intrauterine Procedures

Led by Boston Children's Hospital · Updated on 2024-09-25

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of two new surgical devices, the Karl Storz Curved and Straight Fetoscopes, to assist in minimally invasive in-utero surgeries. These devices help surgeons see inside the uterus during procedures to treat fetal conditions like twin-twin transfusion syndrome and other complex anomalies. The study aims to assess surgical outcomes, complications, and gestational age in patients treated with these scopes, helping to understand their potential benefits in fetal surgery. The curved fetoscope is designed for patients with an anterior placenta, while the straight fetoscope is used for those with a posterior placenta. Both scopes assist in fetoscopic laser photocoagulation, a procedure that seals abnormal blood vessels in the placenta using laser energy. This research is a non-randomized, single arm study where eligible patients undergo intrauterine procedures with either the curved or straight scopes based on placenta position. The study will collect data on the success of the procedures and related complications for descriptive analysis. Participants will be monitored through the procedure and follow-up until birth and shortly after. The study will evaluate outcomes such as the rate of completed fetoscopic procedures, fetal survival at birth, and various maternal and fetal complications. Researchers will also track gestational age at delivery, procedure length, and short-term neonatal health. The total study duration extends over several years to capture both immediate and longer-term results of using these devices in fetal surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years

FEMALE

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 such as a large fibroid tumor in the current pregnancy
Suspicion of a major recognized congenital syndrome on ultrasound or MRI incompatible with postnatal life
Pre-pregnancy maternal BMI greater than 40
High risk for fetal hemophilia
Fetal aneuploidy or variants of known significance if amniocentesis was performed
Contraindication to abdominal surgery or fetoscopic surgery

Research Team

Brittany Gudanowski

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