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NCT Number: NCT06425471

The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

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

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Key information

Conditions

In Utero Procedure Affecting Fetus or Newborn

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KARL STORZ fetoscope arm

Device

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 outcomes

  1. 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

  1. Number of successful procedures with completion of laser ablation of the abnormal vessels.

    Time frame: within 24 hours of in utero surgery

  2. Improved visualization as assessed by the Likert scale

    Time frame: within 24 hours of in utero surgery

    This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes.

  3. Improved angle for laser visualization as assessed by the Likert scale

    Time frame: within 24 hours of in utero surgery

    This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree

  4. Improved ease of use of the new fetoscope as assessed by a questionnaire

    Time frame: within 24 hours of in utero surgery

    This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome

  5. Operative time in minutes

    Time frame: end of surgery ( about 1 hour form start of surgery)

    Time from from operative cannula insertion until it is removed

  6. Number of fetuses alive prior to hospital discharge

    Time frame: time of discharge (about 48 hours after surgery)

  7. Total number of maternal patients that present with short term morbidity

    Time frame: from end of surgery to within 10 weeks after surgery

    Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption

  8. Total number of patients that have maternal and/or fetal perioperative complications

    Time frame: from end of surgery to within 10 weeks after surgery

  9. The number of participants that develop twin-anemia-polycythemia sequence (TAPS)

    Time frame: from end of surgery to within 10 weeks after surgery

  10. Total number of live births

    Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)

  11. Total number of short-term morbidities

    Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)

    Short-term morbidities include, but are not limited to, premature delivery (<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Garcia

CONTACT

[email protected]

713-500-6347

Jimmy Espinoza, MD, MSc,FACOG

CONTACT

[email protected]

(713) 500-5859

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 22, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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