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

Single-center, open-label, exploratory, specified clinical trial confirming initial efficacy and safty of Pneumatic Lymphatic Flow Promoter device in lymphedema patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062220002
Enrollment
20
Registered
2022-04-12
Start date
2022-08-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphedema edema

Interventions

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

Sponsors

YOSHIHIRO KIMATA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Changes in tracer counts around inguinal and popliteal lymph nodes by lymphscintigraphy at rest and the medical device is used for 10 minutes

Secondary

MeasureTime frame
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)

Contacts

Public ContactSHINAOKA AKIRA

Okayama University Faculty of Medicine, Dentistry and Pharmaceutical Sciences

a-shinaoka@okayama-u.ac.jp+81-86-235-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026