Vocal Fold Injection by Platelet Rich Plasma

NCT07350642 | Not Yet Recruiting DMC

• 1 other identifier: vocal fold injection
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

a study to asses safety and efficacy of platelet rich plasma injection in some types of vocal fold problems such as sulcus and atrophy to see the improvement in patient voice and its impact on patient quality of life with a good period of follow up

Conditions

Vocal Fold Sulcus ,Scar and Atrophy

Keywords

Injection; platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• 1-Subjective assessment of the patient using GRBAS scale 2- Subjective assessment of the patien by Arabic version of VHI •3- objective assessment of the patient using video stereoscopic examination and Acoustic analysis • 4-Improvement of patient voice

  Arabic version of VHI is a type of questionnaire the smaller score is the better result with a minimum value equal 0 and the maximum one equal 120,viedo stereoscopic examination is done by flexible nasofiberoscopy ,Acoustic analysis is a computerized system to measure different voice parameters ex fundamental frequency ,jitter and shimmer.

  4 years

Study Arms (1)

patients with vocal fold scar ,sulcus and atrophy

OTHER

injection of platelet rich plasma in the vocal fold by special needle

Other: injection of platelet rich plasma; Device: Nasofiberoscopy

Interventions

injection of platelet rich plasma OTHER

injection is done percutaneous using a special needle following the guides of surgical anatomy of the neck to reach the area of vocal folds under the effect of local anesthesia and by using nasofiberoscoby

patients with vocal fold scar ,sulcus and atrophy

Nasofiberoscopy DEVICE

It is a type of flexible endoscopies introduced from the patient nose to examine the entire airway reaching the larynx

patients with vocal fold scar ,sulcus and atrophy

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 10 years 2-Gender: both sexes will be included in the study 3-clinical diagnosis of vocal fold sulcus, scar or atrophy. 4-Diagnosis confirmed by video laryngoscope examination. 5-be able to participate and sign informed consent.

You may not qualify if:

• Laryngeal cancer. 2. Acute laryngeal infection . 3. Systemic diseases that may impair healing, such as:(Uncontrolled diabetes mellitus-Autoimmune disorders affecting the larynx-Coagulopathy or bleeding disorders).
• \. Use of systemic corticosteroids or immunosuppressive drugs within the last 4 weeks.
• \. Previous laryngeal surgery within the last 6 months 6. Pregnancy or lactation. 7. Known allergy or hypersensitivity to local anesthetics or any component used in PRP preparation.
• \. Inability to complete with follow-up visits or voice assessment protocols

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university

Asyut, Egypt

Location

Faculty of medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eman sayed hassan sayed eman hassan, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Aya Essam Sheakawy Essam Aya Shrakawy, Assistant lecture

CONTACT

+2 01008137079; dr.aya.elsharkawy93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 20, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)