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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBoston Children's Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Karl Storz Curved Scope
  • Karl Storz Straight Scope

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators