Novel Bioactive Sleeve on Pain and PROMs

Part of paid clinical trials in Woodbury, New York.

Sponsor
Northwell Health
Study ID
NCT06041321
Status
Recruiting
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Conditions

  • Meniscus Tear

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Reparel Sleeve — DEVICE
    For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.
  • Placebo Sleeve — DEVICE
    Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.

Study Details

A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.

Key Dates

Start date
Dec 6, 2023
Status verified
Jan 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Reparel Sleeve
    Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down. 501k exempt: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking/Medical Support
  • Placebo Comparator: Placebo Sleeve
    Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra

Primary Outcome Measure

Visual Analogue Scale (VAS) pain score [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlin and Cohen OrthopedicsWoodburyNew York11797
Nadia Baichoo, MA
[email protected]
James Paci, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Orlin and Cohen Orthopedics· Woodbury, NY

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