LymphoPilot Test for Limb Lymphedema

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm or leg and drains excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump. The subcutaneous implantation of the device is performed in loco-regional or general anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure. The device is activated in the postoperative room by placing the external wearable device on patient's limb, in proximity of the implanted pump. Patients are required to wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. Follow-up visits are planned 1, 4 and 8 weeks after device implantation. The implanted device is removed with a surgical procedure in local anesthesia 8 weeks after device implantation, and 2 additional follow-up visits are planned after device removal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04858230
Study type	Interventional
Source	Lymphatica Medtech SA
Contact
Status	Terminated
Phase	N/A
Start date	September 8, 2021
Completion date	September 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04575636` - MRL in the Upper Extremity	N/A
Completed	`NCT03252145` - Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device	N/A
Active, not recruiting	`NCT05441943` - Lymphaticovenous Anastomosis as Treatment for Lymphedema	N/A
Completed	`NCT05754346` - Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema	N/A
Not yet recruiting	`NCT06264817` - Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.	N/A
Completed	`NCT06399458` - The Relationship Between Primary Lymphedema and Joint Hypermobility
Recruiting	`NCT06302361` - Lymphovenous Anastomosis for Breast Cancer Lymphedema	N/A
Active, not recruiting	`NCT06278298` - Different Level of ECSWT in Post Mastectomy Lymphedema	N/A
Completed	`NCT05037708` - Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer	N/A
Not yet recruiting	`NCT02453295` - Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema	N/A
Completed	`NCT05660590` - Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema	N/A
Withdrawn	`NCT02458391` - Complete Decongestive Therapy in Breast Cancer-Related Lymphedema	N/A
Completed	`NCT04766489` - Evaluation of the Treatment Response in Breast Cancer Related Lymphedema	N/A
Enrolling by invitation	`NCT04165512` - Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema	N/A
Recruiting	`NCT05762224` - Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy	N/A
Recruiting	`NCT06082349` - The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema	N/A
Recruiting	`NCT05142800` - Screening For BCRL In Targeted Therapy For Breast Cancer
Recruiting	`NCT06012786` - Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
Not yet recruiting	`NCT06113627` - Lymphatic Response to Resistance Exercise in Breast Cancer Survivors	N/A
Completed	`NCT06036173` - Body Awareness and Functionality in Lymphedema