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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: December 19, 2013
Last updated: October 18, 2016
Last verified: October 2016
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

Condition Intervention Phase
Post Mastectomy
Procedure: Lymphaticovenous Micro-Anastomosis
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Changes relative to baseline in the volume of the affected limb at 3 and 6 months from surgery [ Time Frame: 3 and 6 months from surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: September 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lymphaticovenous Micro-Anastomosis Procedure: Lymphaticovenous Micro-Anastomosis


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02020837

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Mauricio Moreno, MD University of Arkansas
  More Information

Responsible Party: University of Arkansas Identifier: NCT02020837     History of Changes
Other Study ID Numbers: 202676 
Study First Received: December 19, 2013
Last Updated: October 18, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphatic Diseases processed this record on October 25, 2016