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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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

Conditions

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In Utero Procedure Affecting Fetus or Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KARL STORZ fetoscope arm

Group Type EXPERIMENTAL

KARL STORZ fetoscope arm

Intervention Type 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)

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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jimmy Espinoza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jimmy Espinoza, MD, MSc,FACOG

Role: CONTACT

(713) 500-5859

Elisa Garcia

Role: CONTACT

713-500-6347

Facility Contacts

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Jimmy Espinoza, MD, MSc,FACOG

Role: primary

(713) 500-5859

Elisa Garcia

Role: backup

713-500-6347

Other Identifiers

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HSC-MS-22-1019

Identifier Type: -

Identifier Source: org_study_id

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