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NCT Number: NCT06084247

The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses

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).

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Key information

Conditions

Twin to Twin Transfusion Syndrome Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetofetal Transfusion Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Curved KARL STORZ fetoscope

Device

The KARLZ STORZ curved scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery, similar to conventional scopes. The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.

Conventional Scopes

Device

The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

Primary outcomes

  1. Operative time in minutes

    Time frame: during surgery

    Time from from operative cannula insertion until it is removed

Secondary outcomes

  1. Number of Participants that have a gestational age of less than 37 weeks

    Time frame: at time of delivery (about 20 weeks from surgery)

  2. Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention

    Time frame: end of surgery (about 60 minutes after start of surgery)

  3. Total number of procedures with completion of the laser ablation

    Time frame: end of surgery (about 60 minutes after start of surgery)

  4. Improved visualization as assessed by the Likert scale

    Time frame: end of surgery (about 60 minutes after start of 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.

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

    Time frame: end of surgery (about 60 minutes after start of surgery)

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

  6. Total number of fetuses alive, after the laser photocoagulation procedure

    Time frame: at discharge from hospital (about 24 hours after surgery)

  7. Total number of maternal patients that present with morbidity

    Time frame: at discharge from hospital (about 24 hours after surgery)

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

    Time frame: end of surgery (about 60 minutes after start of surgery)

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

    Time frame: end of surgery (about 60 minutes after start of surgery)

  10. Number of live births

    Time frame: at time of delivery (about 20 weeks from surgery)

  11. Number of neonates with a short-term morbidity

    Time frame: from birth until hospital discharge

  12. Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)

    Time frame: 24 months of age

    Scored items on ASQ-3 address 5 areas of child development: communication, gross motor, Fine motor, problem solving, and personal-social and each of these have 6 questions each and is scored as yes( 10 points), sometimes (5 points) and not yet (0 points)-the total score is calculated for each area and scores should fall between 0-60, and a higher score indicates more development.

    There is a 9 item overall developmental section that is answered categorically as yes or no answer

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

Jimmy Espinoza

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 16, 2023
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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