A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
NCT ID: NCT02020837
Last Updated: 2018-06-27
Study Results
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View full resultsBasic Information
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TERMINATED
EARLY_PHASE1
2 participants
INTERVENTIONAL
2014-09-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lymphaticovenous Micro-Anastomosis
Lymphaticovenous Micro-Anastomosis
Interventions
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Lymphaticovenous Micro-Anastomosis
Eligibility Criteria
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Inclusion Criteria
* Subject is Stage II-IV unilateral lymphedema
Exclusion Criteria
* Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
* Subject is medically unfit for the procedure
* Subject is unable to complete the follow-up visits
* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
* Subject has bilateral lymphedema
18 Years
70 Years
ALL
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Mauricio Moreno, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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202676
Identifier Type: -
Identifier Source: org_study_id
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