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Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.

NCT05555602 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-09-27

No results posted yet for this study

Summary

To investigate the effect of 10,600 nm CO2 laser combined with Zimmer Cryo 6 forced cold air device on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.

Conditions

  • Cryotherapy Effect
  • Burn Scar
  • Scar; Previous Cesarean Section

Interventions

DEVICE

Cold-air cooling

Cryo 6 works with a compressor system like those in refrigerators and uses ambient air to generate a permanent stream of cold air with a maximum flow to 1000 L/min and a temperature as low as -30°C, depending on the cooling delivery system and the desired cooling level (range 1-9).

Sponsors & Collaborators

  • Zimmer Medical Devices (Shanghai) Co., Ltd.

    collaborator UNKNOWN

  • Kaiyang Lv, MD-PhD

    lead OTHER

Principal Investigators

  • Yo-Yu Tseng, M.Sc · Zimmer Medical Devices (Shanghai) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-06-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555602 on ClinicalTrials.gov