Laser Photocoagulation in Twin to Twin Transfusion Syndrome

NCT02506049 | Completed

• 1 other identifier: 10-00755-HUD
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).

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 Photocoagulation DEVICE

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

Eligibility Criteria

• Age: 16 Weeks - 27 Weeks
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• University of Tennessee: lead
• Regional Medical Center, Regional One Health: collaborator

Study Sites (2)

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

Memphis, Tennessee, 38103, United States

Location

University of Tennessee Health Science Center, OB-GYN

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, 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

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 1, 2010
• Primary Completion: August 15, 2020
• Study Completion: October 28, 2020
• Last Updated: November 13, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)