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

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ClinicalTrials.gov Identifier: NCT02020837
Recruitment Status : Terminated (Halted prematurely due to low enrollment)
First Posted : December 25, 2013
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphedema Post Mastectomy Procedure: Lymphaticovenous Micro-Anastomosis Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Study Start Date : September 2014
Actual Primary Completion Date : December 3, 2015
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lymphaticovenous Micro-Anastomosis Procedure: Lymphaticovenous Micro-Anastomosis



Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020837


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

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02020837     History of Changes
Other Study ID Numbers: 202676
First Posted: December 25, 2013    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes