Clinical trial NCT06425471: The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Official title: A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: In Utero Procedure Affecting Fetus or Newborn
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

Detailed description: Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes

Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
* Patient of the baby 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
* 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: Gestational age at delivery in patients requiring percutaneous in-utero surgery
timeFrame: at time of delivery (about 10 weeks after in utero surgery)
Secondary outcomes:
measure: Number of successful procedures with completion of laser ablation of the abnormal vessels.
timeFrame: within 24 hours of in utero surgery
measure: Improved visualization as assessed by the Likert scale
timeFrame: within 24 hours of in utero surgery
measure: Improved angle for laser visualization as assessed by the Likert scale
timeFrame: within 24 hours of in utero surgery
measure: Improved ease of use of the new fetoscope as assessed by a questionnaire
timeFrame: within 24 hours of in utero surgery
measure: Operative time in minutes
timeFrame: end of surgery ( about 1 hour form start of surgery)
measure: Number of fetuses alive prior to hospital discharge
timeFrame: time of discharge (about 48 hours after surgery)
measure: Total number of maternal patients that present with short term morbidity
timeFrame: from end of surgery to within 10 weeks after surgery
measure: Total number of patients that have maternal and/or fetal perioperative complications
timeFrame: from end of surgery to within 10 weeks after surgery
measure: The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
timeFrame: from end of surgery to within 10 weeks after surgery
measure: Total number of live births
timeFrame: from time of in utero surgery till delivery (about 10 weeks after surgery)
measure: Total number of short-term morbidities
timeFrame: from time of in utero surgery till delivery (about 10 weeks after surgery)
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: