The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses
NCT ID: NCT06084247
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-09-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KARL STORZ Curved Scope
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.
Conventional scopes
Conventional Scopes
The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.
Interventions
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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.
Conventional Scopes
The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Jimmy Espinoza
OTHER
Responsible Party
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Jimmy Espinoza
Professor
Principal Investigators
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Jimmy Espinoza, MD, MSc,FACOG
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-23-0622
Identifier Type: -
Identifier Source: org_study_id
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