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临床试验/NCT03749863
NCT03749863已完成不适用

Safety and Efficacy of Serial Platelet-Rich Plasma Injections for Treatment of Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

University of Southern California2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

研究概览

简要总结

This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency

详细描述

Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
  • Patients with a pre-injection VHI-10 score of ≥ 10
  • Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
  • Ability to give informed consent

排除标准

  • Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
  • Current smoker
  • Underlying coagulopathy, thrombocytopenia, or platelet dysfunction

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

时间窗: 4 months

Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening

次要结局

  • Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form(4 months)
  • Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)(4 months)
  • Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Johns

Professor, Otolaryngology-Head and Neck Surgery; Director, USC Voice Center

University of Southern California

研究点 (2)

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