CompletedPhase 1

Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold

China20 participantsStarted 2015-12

Plain-language summary

This study is carried out to explore the short-term and long-term efficacy of the functional collagen scaffold in guiding laryngeal soft tissue regeneration.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age of 18-65 years old, male or female
✓. Severe unilateral vocal cord injury and poor closure of the glottis
✓. Disease course was more than 1 year
✓. At least two GRBAS scores reach 2 points or more
✓. The subjects have read and fully understood the research notes, signed informed consent

Exclusion criteria

✕. Over speaking professionals, such as teachers, shop assistants.
✕. With vital organ dysfunction, such as heart, lung, liver or kidney.
✕. Pregnant or lactating women, or in preconception period.
✕. Allergic to various drugs.
✕. Difficult to be followed-up or cooperate long-termly.
✕. Participated in other clinical trials in the last 3 months.
✕. With progressive severe disease.
✕. Alcoholics or drug addicts.

What they're measuring

Change in subjective auditory perception score

Timeframe: 1 week, 2 week, 1,3,6,12 month after intervention

Trial details

NCT IDNCT02754284

SponsorChinese Academy of Sciences

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-06

View on ClinicalTrials.gov More Vocal Cord Dysfunction trials