Status:
NOT_YET_RECRUITING
The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Lead Sponsor:
Jimmy Espinoza
Conditions:
Twin to Twin Transfusion Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06084247
Start Date
September 1 2025
End Date
December 1 2027
Last Update
August 14 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030