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

NCT ID: NCT02020837

Last Updated: 2018-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Lymphedema Post Mastectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lymphaticovenous Micro-Anastomosis

Group Type EXPERIMENTAL

Lymphaticovenous Micro-Anastomosis

Intervention Type PROCEDURE

Interventions

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Lymphaticovenous Micro-Anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mauricio Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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202676

Identifier Type: -

Identifier Source: org_study_id

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