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Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome

NCT05008744 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-04-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.

Conditions

  • Twin to Twin Transfusion as Antepartum Condition
  • Monochorionic Diamniotic Placenta

Interventions

PROCEDURE

Fetoscopic laser ablation

Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Martin P Walker, MD · Seattle Childrens Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2031-10-01
Completion
2031-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008744 on ClinicalTrials.gov