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Laser Photocoagulation in Twin to Twin Transfusion Syndrome

NCT02506049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-11-13

No results posted yet for this study

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

Interventions

DEVICE

S-LPC:Selective Laser Photocoagulation

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.

Sponsors & Collaborators

  • Regional Medical Center, Regional One Health

    collaborator UNKNOWN

  • University of Tennessee

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Weeks
Max Age
27 Weeks
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2020-08-15
Completion
2020-10-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506049 on ClinicalTrials.gov