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

Launched by JIMMY ESPINOZA · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of special tools called fetoscopes, which are used for a procedure called laser photocoagulation to treat a condition known as Twin to Twin Transfusion Syndrome (TTTS). TTTS happens when twins share blood through the placenta unevenly, which can lead to serious health problems for both babies. The study will specifically focus on women who are pregnant with twins and have an anterior placenta, meaning the placenta is located at the front of the uterus.

To be eligible for this trial, participants need to be pregnant with a confirmed diagnosis of TTTS and meet certain medical criteria for the procedure. It's important that they can give informed consent, meaning they understand the risks involved. Women who have certain health issues, like severe obesity or complications in their pregnancy, may not qualify. Those who participate will be closely monitored and can expect to receive care related to their condition during the trial. This study is not yet recruiting participants, but it aims to provide valuable information about the best ways to treat TTTS using these advanced tools.

Gender

FEMALE

Eligibility criteria

• 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