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NCT01622049 · ClinicalTrials.gov registry record
Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome
A clinical trial, sponsored by University of South Florida.
- Completed
- Registry status
- 77
- Enrollment target
NCT01622049 is a clinical trial that has completed, run by University of South Florida. The registered enrollment target is 77 participants.
The verdict
NCT01622049 has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study Summary
Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be
Interventions
- DEVICE Selective Laser Photocoagulation of Communicating Vessels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01622049
The ClinicalTrials.gov registry entry for NCT01622049 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Selective Laser Photocoagulation of Communicating Vessels is the first listed.
NCT01622049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01622049 about?
NCT01622049 is a clinical study titled "Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome". Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment...
What is the current status of trial NCT01622049?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2006-10. Estimated completion is 2009-02.
What interventions are being tested in trial NCT01622049?
The interventions under investigation include: Selective Laser Photocoagulation of Communicating Vessels (DEVICE).
Who is sponsoring clinical trial NCT01622049?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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