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

NCT02020837 | Terminated Early Phase 1 Results DMC

• 1 other identifier: 202676
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphedema; Post Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lymphaticovenous Micro-Anastomosis

EXPERIMENTAL

Procedure: Lymphaticovenous Micro-Anastomosis

Interventions

Lymphaticovenous Micro-Anastomosis PROCEDURE

Lymphaticovenous Micro-Anastomosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18-70 years of age
• Subject is Stage II-IV unilateral lymphedema

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Beth Scanlan
• Organization: University of Arkansas for Medical Sciences

BScanlan@uams.edu

5016868274

Study Officials

• Mauricio Moreno, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A lymphatic diversion with lymphaticovenous microanastomosis will be performed.

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: September 1, 2014
• Primary Completion: December 3, 2015
• Study Completion: July 1, 2017
• Last Updated: June 27, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-04

Locations

US (1)