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

Stopped early · Early Phase 1

Conditions studied: Lymphedema, Post Mastectomy

In brief

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

Key facts

Study ID

NCT02020837

Run by

University of Arkansas

People needed

2

Starts

2014-09-01

Expected to finish

2017-07-01

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18-70 years of age
• Subject is Stage II-IV unilateral lymphedema

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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