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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02020837
Other study ID # 202676
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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