Clinical trial NCT06084247: The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
Official title: An Open Label Randomized-control Study on the Efficacy of the KARL STORZ Curved Fetoscope (11508aak) and Its Straight Version (11506aak) for Laser Photocoagulation of Placental Anastomoses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Twin to Twin Transfusion Syndrome
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 an anterior placenta and Twin to Twin Transfusion Syndrome (TTTS).


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

Primary outcomes:
measure: Operative time in minutes
timeFrame: during surgery
Secondary outcomes:
measure: Number of Participants that have a gestational age of less than 37 weeks
timeFrame: at time of delivery (about 20 weeks from surgery)
measure: Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: Total number of procedures with completion of the laser ablation
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: Improved visualization as assessed by the Likert scale
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: Improved angle for laser visualization as assessed by the Likert scale
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: Total number of fetuses alive, after the laser photocoagulation procedure
timeFrame: at discharge from hospital (about 24 hours after surgery)
measure: Total number of maternal patients that present with morbidity
timeFrame: at discharge from hospital (about 24 hours after surgery)
measure: Total number of patients that have maternal and/or fetal perioperative complications
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
timeFrame: end of surgery (about 60 minutes after start of surgery)
measure: Number of live births
timeFrame: at time of delivery (about 20 weeks from surgery)
measure: Number of neonates with a short-term morbidity
timeFrame: from birth until hospital discharge
measure: Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)
timeFrame: 24 months of age
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jimmy Espinoza, MD, MSc,FACOG
role: PRINCIPAL_INVESTIGATOR
References: