NCT02020837TerminatedPhase 1
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- University of Arkansas
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lymphaticovenous Micro-Anastomosis
Experimental
Intervention: Lymphaticovenous Micro-Anastomosis (Procedure)
Outcomes
Primary Outcomes
Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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