A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

Early Phase 1TerminatedNCT02020837

University of Arkansas2 enrolled

Overview

This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphedema Post Mastectomy

Interventions

Lymphaticovenous Micro-AnastomosisPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is 18-70 years of age * Subject is Stage II-IV unilateral lymphedema Exclusion Criteria: * Subject is less than 6 months from completion of cancer treatment * 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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery

Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.

Time frame: 3 and 6 months from surgery

Data from ClinicalTrials.gov

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