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

University of Arkansas

Status and phase

Terminated

Early Phase 1

Conditions

Post Mastectomy

Lymphedema

Treatments

Procedure: Lymphaticovenous Micro-Anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT02020837

202676

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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