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Procedure
Fetoscopic Laser Surgery for Twin to Twin Transfusion Syndrome
N/A
Waitlist Available
Led By Jimmy Espinoza, MD, MSc,FACOG
Research Sponsored by Jimmy Espinoza
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fetal diagnosis of twin-to-twin transfusion syndrome
Be between 18 and 65 years old
Must not have
The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery
Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months of age
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two types of fetoscope for laser surgeries to treat placenta issues in pregnant women.
Who is the study for?
This trial is for pregnant individuals diagnosed with Twin to Twin Transfusion Syndrome (TTTS) who have an anterior placenta and meet the standard criteria for laser photocoagulation. They must consent to the risks of fetoscopic surgery. Excluded are those with contraindications to abdominal or fetoscopic surgery, general anesthesia allergies, preterm labor, preeclampsia, significant uterine anomalies, fetal genetic abnormalities or syndromes, or a maternal BMI over 40.
What is being tested?
The study compares two types of fetoscopes: KARL STORZ's curved (11508AAK) and straight (11506AAK) models in performing laser photocoagulation on the placenta in TTTS cases. The goal is to determine which scope design offers better outcomes during this delicate surgical procedure.
What are the potential side effects?
Potential side effects from using either fetoscope may include complications related to fetoscopic surgery such as bleeding, amniotic fluid leakage, membrane damage or infection. General anesthesia risks also apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My unborn twins have been diagnosed with twin-to-twin transfusion syndrome.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not eligible for in-utero surgery based on standard criteria.
Select...
I cannot undergo abdominal or fetoscopic surgery, or be put under general anesthesia.
Select...
I have had complications like preterm labor or preeclampsia, or a uterine issue that can't be avoided during surgery in my current pregnancy.
Select...
My unborn baby has been diagnosed with a genetic condition or significant health issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months of age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Operative time in minutes
Secondary study objectives
Improved angle for laser visualization as assessed by the Likert scale
Improved visualization as assessed by the Likert scale
Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KARL STORZ Curved ScopeExperimental Treatment1 Intervention
Group II: Conventional scopesActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Jimmy EspinozaLead Sponsor
Jimmy Espinoza, MD, MSc,FACOGPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
50 Total Patients Enrolled