Clinical trial NCT06022510: Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation
Official title: Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation for Complicated Monochorionic-Diamniotic Pregnancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Twin Monochorionic Diamniotic Placenta
Keywords: twin-twin transfusion syndrome
TTTS
twin anemia polycythemia sequence
TAPS
selective intrauterine growth restriction
sIUGR
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2023-09-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events
timeFrame: Immediate Post-Procedure Period (from surgery start until surgery finish)
measure: Number of device defects, malfunctions, or failures
timeFrame: Immediate Post-Procedure Period (from surgery start until surgery finish)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital - Pavilion for Women
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Michael A Belfort, MD
role: PRINCIPAL_INVESTIGATOR
References: