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Lymphedema, Secondary clinical trials

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NCT ID: NCT06302361 Recruiting - Lymphedema Clinical Trials

Lymphovenous Anastomosis for Breast Cancer Lymphedema

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment. Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires. Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months. The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated. The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

NCT ID: NCT06082349 Recruiting - Clinical trials for Lymphedema of Upper Limb

The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema

Start date: December 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.

NCT ID: NCT05485454 Completed - Lymphedema Clinical Trials

A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema

Start date: June 11, 2022
Phase: N/A
Study type: Interventional

This study will aim to undertake a preference evaluation comparing the Aria Health Aria Freeā„¢ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas.

NCT ID: NCT05242900 Recruiting - Lymphedema of Leg Clinical Trials

Imaging Sodium and Lymphatics in Lymphedema

Start date: October 10, 2021
Phase:
Study type: Observational

Recent evidence supports lymphatic regulation of tissue sodium handling, however fundamental gaps persist in knowledge regarding the role of lymphatics in human diseases of sodium dysregulation. The goal of this work is to apply novel, noninvasive imaging tools to measure relationships between lymphatic function and tissue sodium in patients with well-characterized lymphedema. Findings are intended to inform mechanisms of lymphatic clearance of tissue sodium, and provide novel imaging biomarkers of lymphedema progression and treatment response.

NCT ID: NCT04934098 Recruiting - Breast Neoplasms Clinical Trials

Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This is a randomized clinical trial with women with lymphedema secondary to breast cancer. The intervention will consist of the use of self-adjusting clothing versus compressive bandaging (routine treatment of the institution). Self-adjusting clothing is expected to be more effective for the treatment of lymphedema reduction, when compared to standard treatment, in addition to promoting a better quality of life and functionality.

NCT ID: NCT04881604 Completed - Breast Neoplasms Clinical Trials

Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This is a randomized clinical trial, in which the use of an Adjustable compression wrap as a compressive therapy to control the upper limb volume of with lymphedema women secondary to breast cancer will be investigated, in comparison to the use of a compression sleeve conventionally used. It is expected that Adjustable compression wrap will be more effective than standard treatment for the control of lymphedema, in addition to promoting a better quality of life and functionality for women.

NCT ID: NCT04858230 Terminated - Clinical trials for Lymphedema of Upper Limb

LymphoPilot Test for Limb Lymphedema

Start date: September 8, 2021
Phase: N/A
Study type: Interventional

The present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, LymphoPilot, in patients suffering from secondary upper limb or lower lymphedema.

NCT ID: NCT04797390 Active, not recruiting - Lymphedema Clinical Trials

A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

NCT ID: NCT04588493 Completed - Lymphedema of Leg Clinical Trials

Secondary Lymphedema Due to Human Adjuvant Disease

Start date: March 1, 2017
Phase:
Study type: Observational

This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.

NCT ID: NCT04457375 Completed - Clinical trials for Lymphedema, Secondary

Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Start date: January 16, 2020
Phase:
Study type: Observational

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.