The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06425471
Status
Recruiting
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Conditions

  • In Utero Procedure Affecting Fetus or Newborn

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • KARL STORZ fetoscope arm — 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)

Study Details

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

Key Dates

Start date
Apr 4, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KARL STORZ fetoscope arm

Primary Outcome Measure

Gestational age at delivery in patients requiring percutaneous in-utero surgery [ Time Frame: at time of delivery (about 10 weeks after in utero surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas health Science Center at HoustonHoustonTexas77030
Jimmy Espinoza, MD, MSc,FACOG
[email protected]
(713) 500-5859
Elisa Garcia
[email protected]
713-500-6347

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By research site
The University of Texas health Science Center at Houston· Houston, TX

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