clinical study confirming initial efficacy and safty of Pneumatic Lymphatic Flow Promoter device in lymphedema patients

JRCT ID: jRCTs062220002

Registered date:12/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: lymphedema
• Date of first enrollment: 22/08/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Among the lymphedema patients, those who receive lymphoscintigraphy for the diagnosis of lymphedema or those who receive lymphoscintigraphy for routine medical care for follow-up of lymphedema are the subjects of this study. The start of rest is the start of the intervention before moving to the shooting table. After a rest period of 30 minutes or more, move to the shooting table and inject the tracer. After injection, beforetaking lymphscintigraphy, wrap the cuff of the test device around the affected limb, take the scintigram anduse this product for 10 minutes, and count the tracer on the peripheral side moving to the lymph nodes in the inguinal region and popliteal region.

Outcome(s)

• Primary Outcome: Changes in tracer counts around inguinal and popliteal lymph nodes by lymphscintigraphy at rest and the medical device is used for 10 minutes

Secondary Outcome

1. Difference in the number of counts depending on mild (stage 0 to 2 early) and severe (stage 2 lat
e to 3) in the ISL lymphedema classification
2. Adverse events and malfunctions
3. Change in the number of counters for each imaging range
4. Change in the number of counters at the tracer injection site (back of the foot)
5. Remaining site of anatomical lymphatic groups (popliteal and inguinal) in lymphatic scintigraphy a
nd Maegawa classification(type1-5, unclassified)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who had lymphscintigraph for diagnosis of lymphatic function or for follow-up to evaluate worsening lymphatic function
2. age over 20
3. patients with infrmed consent

Exclude criteria

1. Patients with a body temperature of 38 degrees Celsius or higher (heated period)
2. Obese patients with lean body mass index (BMI value 18 or less) or BMI value 30 or more
3. Patients with pulmonary edema due to congestive heart failure
4. Patients with deep vein thrombosis, thrombophlebitis, pulmonary embolism or suspected of them
5. Patients with inflammation such as gangrene and wounds on the skin pressed by the sleeve
6. Patients with inflammation such as fractures, ablation, flesh, sprains, tendon sheath inflammation, and wounds in the musculoskeletal system compressed by the sleeve.
7. Patients with sensory impairment in the area compressed by the sleeve
8. Patients using implantable medical electrical equipment such as pacemakers that are susceptible to electromagnetic interference
9. Patients with a history of allergies to 99mTc
10. Pregnant patients
11. Patients who did not obtain document consent
12. Other patients who are judged to be inappropriate as subjects by the principal investigator and the investigator

Related Information

• Primary Sponsor: YOSHIHIRO KIMATA
• Source(s) of Monetary Support: TECHUNO TAKATSUKI CO.,LTD.