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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02020837
• Other study ID #: 202676
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 2014
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2017
• Est. primary completion date: December 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema
• Post Mastectomy

Intervention

Procedure:
• Lymphaticovenous Micro-Anastomosis

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes Relative to Baseline in the Volume of the Affected Limb at 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.	3 and 6 months from surgery