Trial Outcomes & Findings for A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema (NCT NCT02020837)

NCT ID: NCT02020837

Last Updated: 2018-06-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

2 participants

Primary outcome timeframe

3 and 6 months from surgery

Results posted on

2018-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Lymphaticovenous Micro-Anastomosis Lymphaticovenous Micro-Anastomosis
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphaticovenous Micro-Anastomosis n=2 Participants Lymphaticovenous Micro-Anastomosis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Count of Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 and 6 months from surgery

Population: Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.

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.

Outcome measures

Outcome data not reported

Adverse Events

Lymphaticovenous Micro-Anastomosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Scanlan

University of Arkansas for Medical Sciences

Phone: 5016868274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place