Recruiting

Curved & Straight Fetoscope

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06425471

Conditions

In Utero Procedure Affecting Fetus or Newborn

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

KARL STORZ fetoscope arm

Study Details

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

Conditions

In Utero Procedure Affecting Fetus or Newborn

Study ID

NCT06425471

Start date

Apr 4, 2024

Status verified date

Aug, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KARL STORZ fetoscope arm

Interventions

KARL STORZ fetoscope arm

The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)

Primary outcome measure

  • Gestational age at delivery in patients requiring percutaneous in-utero surgery [ Time Frame: at time of delivery (about 10 weeks after in utero surgery) ]

Central Contacts and Locations

Central contacts

Jimmy Espinoza, MD, MSc,FACOG

(713) 500-5859Jimmy.Espinoza@uth.tmc.edu

Elisa Garcia

713-500-6347Elisa.I.Garcia@uth.tmc.edu

Locations

The University of Texas health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jimmy Espinoza, MD, MSc,FACOG

(713) 500-5859Jimmy.Espinoza@uth.tmc.edu

Elisa Garcia

713-500-6347Elisa.I.Garcia@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-08-14.