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Procedure
Fetoscopic Laser Photocoagulation for Twin Placenta Complications
N/A
Waitlist Available
Led By Michael A Belfort, MD
Research Sponsored by Michael A Belfort
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies
Be older than 18 years old
Must not have
Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-procedure period (from surgery start until surgery finish)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new tool for treating complicated pregnancies safely and effectively.
Who is the study for?
This trial is for pregnant individuals with twins sharing one placenta (monochorionic-diamniotic pregnancies) who choose to undergo a procedure called fetoscopic selective laser photocoagulation to treat complications.
What is being tested?
The study is testing new types of fetoscopes, which are special telescopes used in surgery on the fetus. The focus is on their safety and effectiveness when treating twin-to-twin transfusion syndrome via laser therapy.
What are the potential side effects?
While specific side effects aren't listed, procedures involving fetoscopes can potentially lead to bleeding, infection, or damage to the amniotic sac or placenta.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am choosing to have laser surgery for my complicated twin pregnancy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I chose not to have laser treatment for my complicated twin pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate post-procedure period (from surgery start until surgery finish)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-procedure period (from surgery start until surgery finish)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of adverse events
Number of device defects, malfunctions, or failures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fetoscopes for Selective Laser PhotocoagulationExperimental Treatment1 Intervention
Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.
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Who is running the clinical trial?
Michael A BelfortLead Sponsor
4 Previous Clinical Trials
205 Total Patients Enrolled
Baylor College of MedicineOTHER
1,024 Previous Clinical Trials
6,029,195 Total Patients Enrolled
Michael A Belfort, MDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
100 Total Patients Enrolled
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