RecruitingNot ApplicableNCT06056635

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


Sponsor

Boston Children's Hospital

Enrollment

50 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of specialized thin telescopes (fetoscopes) used during minimally invasive surgery inside the womb (in-utero surgery) to treat fetal conditions before birth. **You may be eligible if...** - You are a pregnant patient with a fetal condition that requires in-utero surgery - You are eligible for anesthesia - You and the father of the fetus (if available) can provide signed informed consent **You may NOT be eligible if...** - You have an allergy to any medication required for the procedure without a safe alternative - You have preterm labor, preeclampsia, or a significant uterine abnormality (such as a large fibroid) - Your fetus has a condition not compatible with life after birth - Your pre-pregnancy BMI was greater than 40 - You have a contraindication to abdominal or fetoscopic surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEKarl Storz Curved Scope

The curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

DEVICEKarl Storz Straight Scope

The straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT06056635


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