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

NCT05008744 | Recruiting FDA Device

• 1 other identifier: 00003168
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Twin; Monochorionic; Fetoscopy; Laser

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival to discharge from the nursery of affected babies

  Immediately after the surgery to discharge from the hospital after delivery

Study Arms (1)

Patients presenting with TTTS

Pregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome

Procedure: Fetoscopic laser ablation

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.

Patients presenting with TTTS

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant persons presenting with a diagnosis of twin to twin transfusion syndrome

You may qualify if:

• Single placenta (Monochorionic)
• Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
• Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
• Prominent bladder in the recipient/ non-filling bladder in the donor
• Thin dividing membrane

You may not qualify if:

• Patients unwilling to participate in the study or to be followed up
• Presence of major congenital anomalies incompatible with survival
• Active pre-term labor Ruptured membranes
• Chorioamnionitis
• Vaginal bleeding

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (2)

Seattle Childrens Hospital

Seattle, Washington, 98015, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Amniotic fluid

Study Officials

• Martin P Walker, MD

  Seattle Childrens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin P Walker, MD

CONTACT

206-987-3539; martin.walker@seattlechildrens.org

Melissa Dorn, RN MN

CONTACT

206-987-4137; melissa.dorn@seattlechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Seattle Childrens Fetal Intervention and Surgery Program, Clinical Assistant Professor

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 17, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)