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Lymphedema Arm 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: NCT06144164 Recruiting - Breast Cancer Clinical Trials

A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer

Start date: November 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.

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: NCT05825157 Not yet recruiting - Lymphedema Arm Clinical Trials

Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.

NCT ID: NCT05682885 Recruiting - Clinical trials for Breast Cancer Related Lymphedema

The Effectiveness of Lymphatic Bypass Supermicrosurgery

ELYBS
Start date: October 6, 2022
Phase: N/A
Study type: Interventional

This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).

NCT ID: NCT05613946 Active, not recruiting - Lymphedema Arm Clinical Trials

Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema

CASTLE
Start date: December 15, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

NCT ID: NCT05456568 Completed - Lymphedema of Leg Clinical Trials

LymphAssistTM at Home (LAAH)

LAAH
Start date: July 6, 2022
Phase: N/A
Study type: Interventional

Lymphoedema is a life-long condition causing long-term swelling affecting people physically, mentally and socially. Daily self-management covers four main areas (skin care, activity / movement, compression and massage / light touch). Intensive clinic-based treatments are available alongside usual care, including intermittent pneumatic compression (IPC). Recent studies have explored the feasibility, acceptability and impact of home-based IPC. This study will further our understanding of home-based IPC in a Value-Based procurement study.

NCT ID: NCT05441943 Active, not recruiting - Breast Cancer Clinical Trials

Lymphaticovenous Anastomosis as Treatment for Lymphedema

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

The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.

NCT ID: NCT05142800 Recruiting - Breast Cancer Clinical Trials

Screening For BCRL In Targeted Therapy For Breast Cancer

Start date: December 13, 2018
Phase:
Study type: Observational

This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer. A Perometer and Sozo devise will be used to measure volume changes

NCT ID: NCT05064176 Recruiting - Lymphedema Clinical Trials

Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

SurLym
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The primary objective of this research proposal is to investigate - in patients with lymphoedema of the upper limb or lower limb (P) - the added value of reconstructive lymphatic surgery (I) - to the decongestive lymphatic therapy (usual care) (C) - on the lymphoedema-specific quality of life (QoL) (O) - at 18 months post-surgery/ no surgery (T) Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'