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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Fetoscopic laser ablation — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2021

Status verified

Apr 2024

Primary completion

Oct 1, 2031

Completion

Oct 1, 2031

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Patients presenting with TTTS
  Pregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome

Primary Outcome Measure

Survival [ Time Frame: Immediately after the surgery to discharge from the hospital after delivery ]

Central Contacts

• Martin P Walker, MD
  206-987-3539
  [email protected]
• Melissa Dorn, RN MN
  206-987-4137
  [email protected]

Locations (2)

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