The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses

Jimmy Espinoza

Status

Not yet enrolling

Conditions

Twin to Twin Transfusion Syndrome

Treatments

Device: Conventional Scopes

Device: Curved KARL STORZ fetoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT06084247

HSC-MS-23-0622

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and Twin to Twin Transfusion Syndrome (TTTS).

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

pregnancy
The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care
fetal diagnosis of twin-to-twin transfusion syndrome
Anterior placenta
The patient provides signed informed consent that details the maternal and fetal risks involved with the procedure

Exclusion criteria

Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
Allergy or previous adverse reaction to a study medication specified in this protocol
The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery
Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation
Suspicion of a major recognized syndrome by ultrasound or MRI
Maternal BMI >40 kg/m2
High risk for fetal hemophilia