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Procedure

Curved vs Straight Fetoscope for In-Utero Surgery

N/A
Recruiting
Led By Jimmy Espinoza, MD, MSc,FACOG
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of in utero surgery
Awards & highlights

Summary

"This trial aims to compare the effectiveness of two different types of fetoscopes, one curved and one straight, for performing surgery on babies while they are still in the womb."

Who is the study for?
This trial is for pregnant women who meet the criteria for in-utero surgery based on existing medical guidelines. They must provide informed consent acknowledging the risks to both mother and fetus. Women with a BMI over 40, genetic abnormalities in the fetus, or conditions like preeclampsia are excluded.
What is being tested?
The study is comparing two types of fetoscopes by KARL STORZ: a curved model (11508AAK) and a straight one (11506AAK), used during fetal surgery. The goal is to determine which design offers better efficacy for these delicate procedures.
What are the potential side effects?
While specific side effects aren't listed, typical risks associated with fetoscopic surgery may include bleeding, amniotic fluid leakage, preterm labor, and potential harm to the fetus or complications related to anesthesia.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have complications like preterm labor, high blood pressure during pregnancy, or a large fibroid that could affect surgery.
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I cannot undergo abdominal or fetoscopic surgery, or be given general anesthesia.
Select...
My unborn baby has been diagnosed with a genetic condition or significant health issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of in utero surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of in utero surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Improved angle for laser visualization as assessed by the Likert scale
Improved ease of use of the new fetoscope as assessed by a questionnaire
Improved visualization as assessed by the Likert scale
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: KARL STORZ fetoscope armExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
934 Previous Clinical Trials
333,758 Total Patients Enrolled
Jimmy Espinoza, MD, MSc,FACOGPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
160 Total Patients Enrolled
~33 spots leftby Dec 2026
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