Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema

Phase 2

• Conditions: breast cancer-related lymphedema

• Registration Number: JPRN-UMIN000026124
• Lead Sponsor: agoya University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Patients undergoing surgery for bilateral breast cancer or with surgical history of the opposite breast; breast cancer stage4; patients who have trauma with deformation, degenerative diseases or inflammatory diseases in the upper extremities, now or in the past; conditions of double cancers, collagen diseases, rheumatoid arthritis, nephrosis, heart failure, insect bites, cellulitis or other edema; conditions of severe interruption in the circulation, congestive heart failure or phlegmasia cerulea dolens; patients with perceptual disorder or sensory disorder at the Hand Incubator attachment site; patients with inflammation, suppuration, painful skin diseases or wounds at the Hand Incubator attachment site; patients with hypersensitivity to vinyl chloride or polyurethane; patients with allergies to ICG, iodine or hydrogel; patients with implanted pacemaker; pregnant or lactating women; patients who are unable to obtain written informed consent; patients judged to be inappropriate for participation to this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified