LymphoPilot Test for Limb Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphedema, Secondary Lymphedema of Upper Limb Lymphedema Arm Lymphedema of Leg Lymphedema, Lower Limb

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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LymphoPilot

Patient will be implanted with the medical device under investigation, LymphoPilot, through a surgical procedure performed in loco-regional or general anesthesia. Lymphedema outcomes will be monitored for 8 weeks after implantation and compared to baseline values before device implantation. Safety data will be collected throughout the study.

Group Type EXPERIMENTAL

LymphoPilot

Intervention Type DEVICE

LymphoPilot is an investigational medical device composed of an implanted part (pump, drainage catheter and output catheter), implanted in the subcutaneous tissue of the arm or of the leg and draining excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The implanted part is activated and controlled via a wearable device.

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.

Patients will wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. The implanted device will be removed with a surgical procedure in local anesthesia 8 weeks after device implantation.

Interventions

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LymphoPilot

LymphoPilot is an investigational medical device composed of an implanted part (pump, drainage catheter and output catheter), implanted in the subcutaneous tissue of the arm or of the leg and draining excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The implanted part is activated and controlled via a wearable device.

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.

Patients will wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. The implanted device will be removed with a surgical procedure in local anesthesia 8 weeks after device implantation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patients, 18 years and older
* Patients with unilateral secondary upper or lower limb lymphedema.

Exclusion Criteria

* Active cellulitis/infection
* Lymphedema associated with active cancer requiring chemotherapy or radiotherapy
* Motor and sensitive neurological deficiency
* Post-operative edema (i.e. acute edema following breast cancer related surgery)
* Any contraindication to surgery or to loco-regional or general anesthesia
* Patient participating in any other clinical study
* Patient unable to provide informed consent
* Patient with pacemaker
* Pathologies associated with an overload of the cardiac system
* Poor wound healing
* Pregnancy or breastfeeding
* Known intolerance to implantable devices
* Known allergies to silicone
* Patient needing magnetic therapy
* Any other condition that according to the principal investigator makes the patient unsuitable for the participation in the trial
* Patient refusing to receive information about incidental findings on her health status discovered during the clinical investigation
* L-Dex score lower than 6.5 at screening

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No