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

Phase 2

• Conditions: lymphedema; edema

• Registration Number: JPRN-jRCTs062220002
• Lead Sponsor: YOSHIHIRO KIMATA

Brief Summary

In mild lymphedema, IPC enhanced lymphatic flow compared to resting conditions. In severe cases, it was partially promote lymph flow.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Study Completion: 2023-03-08
• Results First Posted: 2023-09-03
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified