A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
NCT07091773 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2025-07-29
Summary
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
Conditions
- Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
Interventions
- DEVICE
-
OLIZ Photobiomodulation Device
OLIZ device utilizes dual-wavelength technology combining specific red (660nm) and near-infrared (850nm) light parameters optimized for post-surgical tissue healing. The device features controlled power density, precise treatment duration protocols, and targeted application to knee arthroplasty surgical sites. Treatment parameters include specific irradiance levels, treatment session duration of 15 minutes, and 3 times of daily application frequency designed.
Sponsors & Collaborators
-
Inje University
collaborator OTHER -
InjeUniversityIlsanPaikHospital
collaborator UNKNOWN -
Gangnam Severance Hospital
collaborator OTHER -
National Medical Center, Seoul
collaborator OTHER -
National Health Insurance Service Ilsan Hospital
collaborator OTHER -
Korea University Anam Hospital
collaborator OTHER -
Samsung Medical Center
collaborator OTHER -
The Catholic University of Korea Uijeongbu St.Marys Hostpial
collaborator UNKNOWN -
LTBIO Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyung Wook Nha, M.D., Ph.D · Inje University Ilsan Paik Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-20
- Primary Completion
- 2026-01-30
- Completion
- 2026-06-30
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