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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02020837
First received: December 19, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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
Lymphedema
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: January 2015
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lymphaticovenous Micro-Anastomosis Procedure: Lymphaticovenous Micro-Anastomosis

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020837

Contacts
Contact: Mauricio Moreno, MD 501-686-7009 mamoreno@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Daisy Wade    501-686-8274    dewade@uams.edu   
Principal Investigator: Mauricio Moreno, MD         
Sub-Investigator: V. Suzanne Klimberg, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Mauricio Moreno, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02020837     History of Changes
Other Study ID Numbers: 202676
Study First Received: December 19, 2013
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014