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Not yet recruiting NCT06084247

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

No phase Interventional Twin to Twin Transfusion Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curved KARL STORZ fetoscope, Conventional Scopes.
Who it may be relevant to
Registry conditions: Twin to Twin Transfusion Syndrome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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).

Interventions

  • Device Curved KARL STORZ fetoscope
    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.
  • Device Conventional Scopes
    The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

Primary outcome measures

  • Operative time in minutes [Time frame: during surgery]
Secondary outcome measures (12)
  • Number of Participants that have a gestational age of less than 37 weeks [Time frame: at time of delivery (about 20 weeks from surgery)]
  • 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)]
  • Total number of procedures with completion of the laser ablation [Time frame: end of surgery (about 60 minutes after start of surgery)]
  • Improved visualization as assessed by the Likert scale [Time frame: end of surgery (about 60 minutes after start of surgery)]
  • Improved angle for laser visualization as assessed by the Likert scale [Time frame: end of surgery (about 60 minutes after start of surgery)]
  • Total number of fetuses alive, after the laser photocoagulation procedure [Time frame: at discharge from hospital (about 24 hours after surgery)]
  • Total number of maternal patients that present with morbidity [Time frame: at discharge from hospital (about 24 hours after surgery)]
  • Total number of patients that have maternal and/or fetal perioperative complications [Time frame: end of surgery (about 60 minutes after start of surgery)]
  • The number of participants that develop twin-anemia-polycythemia sequence (TAPS) [Time frame: end of surgery (about 60 minutes after start of surgery)]
  • Number of live births [Time frame: at time of delivery (about 20 weeks from surgery)]
  • Number of neonates with a short-term morbidity [Time frame: from birth until hospital discharge]
  • Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3) [Time frame: 24 months of age]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06084247 · HSC-MS-23-0622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗