LymphoPilot Test for Limb Lymphedema

Lymphedema of Upper Limb Clinical Trial

Official title:

Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04858230
• Other study ID #: LymphoPilot
• Status: Terminated
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Lymphatica Medtech SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Lymphatica Medtech SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence, frequency and severity of device-related adverse events	Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety	From enrollment until final visit, 4 weeks after device removal.
Secondary	Device functionality evaluated via ultrasound imaging	Ultrasound imaging is used to verify fluid flow in the implanted catheters	At day 1 (implant surgery), day 7, day 28 and day 56
Secondary	Limb volume	Arm or leg volume evaluated by tape measure and by perometer	At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
Secondary	L-Dex score	L-Dex score is measured via bioimpedance spectroscopy	At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
Secondary	Upper extremity function	The Quick Disability of Arm, Shoulder, Hand Questionnaire (DASH) is used to evaluate upper extremity function	At day 0 (baseline) and at day 56
Secondary	Lower extremity function	The Lower Extremity Functional Scale (LEFS) is used to evaluate lower extremity function	At day 0 (baseline) and at day 56
Secondary	Physical functioning evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's physical functioning.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Role limitations due to physical health evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to physical health.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Role limitations due to emotional problems evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to emotional problems.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Energy/fatigue evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's energy/fatigue.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Emotional well-being evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's emotional well-being.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Social functioning evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's social functioning.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Pain evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's pain. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	General health evaluated via validated SF-36 questionnaire	The Short Form-36 (SF-36) questionnaire is used to evaluate patient's general health.; Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.	At day 0 (baseline) and at day 56
Secondary	Quality of life evaluated via validated LYMQOL-leg questionnaire	The Lymphedema Quality of Life Questionnaire for leg Lymphedema (LYMQOL-LEG) questionnaire is used to evaluate assessing problems in functioning in patients with lower limb lymphedema.; Scoring scale: 0-10, where highest scores represent the best outcome.	At day 7 and at day 56
Secondary	Quality of life evaluated via validated LYMPH-ICF-UL questionnaire	The Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (LYMPH-ICF-UL) questionnaire is used to evaluate assessing problems in functioning in patients with upper limb lymphedema.; Scoring scale: 0-100, where highest scores mean a worse outcome.	At day 7 and at day 56
Secondary	Ease of use of the device	Device usability evaluated via dedicated survey	At day 7 and at day 56