Trials Sponsors Conditions Drugs Pricing

Conditions

Twin to Twin Transfusion Syndrome

Outcome Measures

Primary Outcomes (1)

Laser ablation of placental anastomoses for treatment of severe TTTS and establishment of normalized blood flow between the fetal twins.
Once a diagnosis of TTTS has been made, the Fetoscopy Instrument Sets are intended to be used for selective laser photocoagulation (S-LPC) to treat the condition in fetuses whose gestational age is between 16 and 26 weeks. The set consists of a fetoscope, which is essentially an optical device used to view a fetus within the uterus, and sheaths that are used to pass other surgical instruments and/or fluid through the entry site, which is a tiny incision in the mother's abdomen. The instruments are inserted using ultrasound guidance and, once the shared blood vessels on the placenta are identified using the fetoscope, a laser can be passed through the sheath. The laser is used to photocoagulate the shared vessels. This helps to normalize the flow of blood between the twins. After all target vessels are identified and treated with S-LPC, the laser, fetoscope, and sheath are removed.
The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation;procedure will last approx 1 hour

Study Arms (1)

S-LPC:Selective Laser Photocoagulation

OTHER

S-LPC seals connecting vessels, normalizes flow between twins

Device: S-LPC:Selective Laser Photocoagulation

Interventions

S-LPC:Selective Laser PhotocoagulationDevice

Under anesthesia (epidural, general anesthesia with intubation, or intravenous sedation with infiltration of a local anesthetic), one treatment with the use of fetoscopy instrument sets for Selective Laser Photocoagulation (S-PLC) to seal the connecting blood vessels, help to normalize blood flow between twins.

S-LPC:Selective Laser Photocoagulation

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Eligibility Criteria

Age16 Weeks - 27 Weeks

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

The device will be used in multifetal pregnancies affected with twin-to-twin transfusion syndrome (TTTS) at less than 27 weeks of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Regional Medical Center, Regional One Health
Type not reportedcollaborator
University of Tennessee
Otherlead

Study Sites (2)

Regional One Health, Regional Medical Center, Rout Center for Women and Children

Memphis, Tennessee, 38103, United States

University of Tennessee Health Science Center, OB-GYN

Memphis, Tennessee, 38103, United States

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Giancarlo Mari, M.D., MBA
Prof. & Chair, UTHSC; Dir.,TN Inst. of Feto-Maternal & Infant Health; Dir., High-Risk Obstetrics Ctr of Excell., Regional Medical Ctr
PRINCIPAL INVESTIGATOR

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 22, 2015

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

Laser Photocoagulation in Twin to Twin Transfusion Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

S-LPC:Selective Laser Photocoagulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

S-LPC:Selective Laser Photocoagulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations