Back to resultsA Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Primary Purpose
Lymphedema, Post Mastectomy
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lymphaticovenous Micro-Anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lymphaticovenous Micro-Anastomosis
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02020837
First Posted
December 19, 2013
Last Updated
April 6, 2018
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT02020837
Brief Title
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Official Title
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Halted prematurely due to low enrollment
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 3, 2015 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Post Mastectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lymphaticovenous Micro-Anastomosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Lymphaticovenous Micro-Anastomosis
Primary Outcome Measure Information:
Title
Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Description
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.
Time Frame
3 and 6 months from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Moreno, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
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