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

University of Arkansas1 site in 1 country2 target enrollmentSeptember 2014

ConditionsLymphedema Post Mastectomy

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Lymphedema
Sponsor: University of Arkansas
Enrollment: 2
Locations: 1
Primary Endpoint: Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

July 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Arkansas

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.