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.
Conditions
Fetal Conditions, Maternal; Procedure, Pregnancy Related, Twin to Twin Transfusion Syndrome, In Utero Procedure Affecting Fetus or Newborn, Chorion; Abnormal, Twin Reversal Arterial Perfusion Syndrome, Twin Monochorionic Monoamniotic Placenta, Chorioangioma, Vasa Previa
Recruitment Status
Not yet recruiting
Detailed Description
The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes. Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios. This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
Eligibility Criteria
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
Intervention
Intervention Type
Intervention Name
Device
Karl Storz Curved Scope
Device
Karl Storz Straight Scope
Phase
Not Applicable
Gender
Female
Min Age
18 Years
Max Age
45 Years
Download Date
February 28, 2024
Principal Investigator
Principal Investigator: Eyal Krispin, MD
Sub-Investigator: Alireza Shamshirsaz, MD
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
MFCCFetalResearchStudies-dl@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: