Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation

Study Overview
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Brief Summary
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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.

Detailed Description
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All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent. Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the treatment of complicated monochorionic twin pregnancies and will be performed with the same technique in this study as it is with the use of the currently approved fetoscopes. In the majority of cases, in utero access has been achieved using a small percutaneous incision under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine wall and into the recipient fetus' gestational sac. The fetoscope is then used to map the placental vascular pattern. Communicating vessels between the fetuses are ablated using laser energy via a 400-600 micron laser fiber that has been introduced through the instrument channel of the operating sheath. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure. At the completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to achieve a normal volume. Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).

Official Title
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Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation for Complicated Monochorionic-Diamniotic Pregnancies

Conditions
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Twin Monochorionic Diamniotic Placenta

Intervention / Treatment
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* Device: Fetoscopy Sets for Anterior and Posterior Placentas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies. Exclusion Criteria: Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetoscopes for Selective Laser Photocoagulation<br>Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study. | Device: Fetoscopy Sets for Anterior and Posterior Placentas<br>* Patients who choose to undergo fetoscopic surgery for a complicated monochorionic-diamniotic pregnancy will be offered participation in this study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.<br>* Other names: Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Curved or 11508 AAK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of adverse events associated with the investigational device. | Immediate Post-Procedure Period (from surgery start until surgery finish) | 
| Number of device defects, malfunctions, or failures | Number of device defects, malfunctions, or failures and whether the device performed as intended. | Immediate Post-Procedure Period (from surgery start until surgery finish) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTTS, twin-twin transfusion syndrome, twin anemia polycythemia sequence, TAPS, selective intrauterine growth restriction, sIUGR