Fetoscopic Laser Photocoagulation for Twin Placenta Complications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies.
Research Team
MA
Michael A Belfort, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
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.Inclusion Criteria
I am choosing to have laser surgery for my complicated twin pregnancy.
Exclusion Criteria
I chose not to have laser treatment for my complicated twin pregnancy.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo fetoscopic selective laser photocoagulation using investigational fetoscopes
Immediate procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness immediately after the procedure
Immediate post-procedure period
Treatment Details
Interventions
- Fetoscopic Selective Laser Photocoagulation
- Fetoscopy Sets for Anterior and Posterior Placentas
Trial Overview 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.
Participant Groups
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 Belfort
Lead Sponsor
Trials
5
Recruited
510+
Baylor College of Medicine
Collaborator
Trials
1,044
Recruited
6,031,000+
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