Trials Sponsors Conditions Drugs Pricing

Conditions

Monochorionic Diamniotic Placenta Twin to Twin Transfusion as Antepartum Condition

Keywords

TwinMonochorionicFetoscopyLaser

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 ablationProcedure

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Single placenta (Monochorionic)

Sponsors & Collaborators

Seattle Children's Hospital
Otherlead

Study Sites (2)

Seattle Childrens Hospital

Seattle, Washington, 98015, United States

RECRUITING

Martin P Walker, MDCONTACT206-987-3539 ext. 73539 martin.walker@seattlechildrens.org

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

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

Actual (reported)

Primary Completion

October 1, 2031

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients presenting with TTTS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients presenting with TTTS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations