Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02020837
Recruitment Status : Terminated (Halted prematurely due to low enrollment)
First Posted : December 25, 2013
Results First Posted : April 9, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphedema
Post Mastectomy
Intervention Procedure: Lymphaticovenous Micro-Anastomosis
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lymphaticovenous Micro-Anastomosis
Hide Arm/Group Description Lymphaticovenous Micro-Anastomosis
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Lymphaticovenous Micro-Anastomosis
Hide Arm/Group Description Lymphaticovenous Micro-Anastomosis
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Count of Participants   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
2
 100.0%
[1]
Measure Description: Number of participants
1.Primary Outcome
Title Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.
Arm/Group Title Lymphaticovenous Micro-Anastomosis
Hide Arm/Group Description:
Lymphaticovenous Micro-Anastomosis
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lymphaticovenous Micro-Anastomosis
Hide Arm/Group Description Lymphaticovenous Micro-Anastomosis
All-Cause Mortality
Lymphaticovenous Micro-Anastomosis
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lymphaticovenous Micro-Anastomosis
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lymphaticovenous Micro-Anastomosis
Affected / at Risk (%)
Total   0/2 (0.00%) 
Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Beth Scanlan
Organization: University of Arkansas for Medical Sciences
Phone: 5016868274
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02020837     History of Changes
Other Study ID Numbers: 202676
First Submitted: December 19, 2013
First Posted: December 25, 2013
Results First Submitted: August 9, 2017
Results First Posted: April 9, 2018
Last Update Posted: June 27, 2018