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Clinical Trials/NCT06425471
NCT06425471RecruitingNot Applicable

A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

The University of Texas Health Science Center, Houston2 sites in 1 country50 target enrollmentStarted: April 4, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
2
Primary Endpoint
Gestational age at delivery in patients requiring percutaneous in-utero surgery
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Gestational age at delivery in patients requiring percutaneous in-utero surgery

Time Frame: at time of delivery (about 10 weeks after in utero surgery)

Secondary Outcomes

  • Number of successful procedures with completion of laser ablation of the abnormal vessels.(within 24 hours of in utero surgery)
  • Improved visualization as assessed by the Likert scale(within 24 hours of in utero surgery)
  • Improved ease of use of the new fetoscope as assessed by a questionnaire(within 24 hours of in utero surgery)
  • Operative time in minutes(end of surgery ( about 1 hour form start of surgery))
  • Number of fetuses alive prior to hospital discharge(time of discharge (about 48 hours after surgery))
  • The number of participants that develop twin-anemia-polycythemia sequence (TAPS)(from end of surgery to within 10 weeks after surgery)
  • Total number of live births(from time of in utero surgery till delivery (about 10 weeks after surgery))
  • Improved angle for laser visualization as assessed by the Likert scale(within 24 hours of in utero surgery)
  • Total number of patients that have maternal and/or fetal perioperative complications(from end of surgery to within 10 weeks after surgery)
  • Total number of maternal patients that present with short term morbidity(from end of surgery to within 10 weeks after surgery)
  • Total number of short-term morbidities(from time of in utero surgery till delivery (about 10 weeks after surgery))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jimmy Espinoza

Professor

The University of Texas Health Science Center, Houston

Study Sites (2)

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