The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
NCT ID: NCT06425471
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-04
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KARL STORZ fetoscope arm
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
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-22-1019
Identifier Type: -
Identifier Source: org_study_id
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